- The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).
- Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).
- The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
- Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).
- Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
- Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).
- Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).
- The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline. [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).
- Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).
- The Mean Absolute Values of FSFI Total Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
- The Mean Absolute Values of FSFI Total Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
- Mean Change From Baseline to Cycle 6 in FSFI Total Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).
- The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).
- The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).
- Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).
- The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).
- The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).
- Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant
- Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.
- Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).
- Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
- Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
- Vaginal Effects Evaluated by Vaginal pH at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick
- Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).
- Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).
- Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).
- Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).
- Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).
- Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).
- Number of Bleeding / Spotting Days in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Number of Bleeding / Spotting Days in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to 180 during study treatment
- Number of Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes
- Number of Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment
- Mean Length of Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes
- Mean Length of Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Maximum Length of Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Maximum Length of Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Number of Spotting Only Days in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Number of Spotting Only Days in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Number of Spotting Only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Number of Spotting Only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Mean Length of Spotting-only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Mean Length of Spotting-only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Maximum Length of Spotting-only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Maximum Length of Spotting-only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
- Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
- Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
- Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
- Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
- Length of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
- Length of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
- Length of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end
- Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
- Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
- Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
- Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
- Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
- Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.
- Onset of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1 ] [ Designated as safety issue: No ]
Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
- Onset of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3 ] [ Designated as safety issue: No ]
Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
- Onset of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6 ] [ Designated as safety issue: No ]
Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.
- Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Number of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Number of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Number of Intracyclic Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Maximum Length of Intracyclic Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Number of Intracyclic Bleeding Days at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Number of Intracyclic Bleeding Days at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Number of Intracyclic Bleeding Days at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
- Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
- Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
- Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.
- Percentage of Participants With at Least 1 Intracyclic Bleeding Episode [ Time Frame: Up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Purpose
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