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Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives

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ClinicalTrials.gov Identifier: NCT00089414
Recruitment Status : Terminated (Informed by manufacturer that CDB-2914 crosses blood-brain barrier invalidating Arm #3 of protocol.)
First Posted : August 5, 2004
Results First Posted : January 2, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Premenstrual Syndrome
PMS
Premenstrual Dysphoric Disorder
PMDD
Depression
Interventions Drug: Ethinyl Estradiol/Drospirenone
Drug: Placebo
Drug: CDB 2914
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuous Yasmin Interrupted Yasmin Continuous Yasmin Plus Progesterone Antagonist
Hide Arm/Group Description Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle. Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo). Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
Period Title: Overall Study
Started 2 1 2
Completed 2 1 2
Not Completed 0 0 0
Arm/Group Title Continuous OCP Plus Placebo Interrupted OC Continuous OC Plus PR Antagonist Total
Hide Arm/Group Description Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle. Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo). Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses. Total of all reporting groups
Overall Number of Baseline Participants 2 1 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 2 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
2
 100.0%
5
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 2 participants 5 participants
31.5  (6.364) 41  (0) 34.5  (2.121) 34.6  (3.8794)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 2 participants 5 participants
Female
2
 100.0%
1
 100.0%
2
 100.0%
5
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 2 participants 5 participants
2 1 2 5
1.Primary Outcome
Title Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.
Hide Description The PMTS observer scales assess symptoms in ten different domains including irritability-hostility; tension; efficiency; dysphoria; moodiness; motor coordination; mental-cognitive functioning; eating habits; sexual drive and activity; physical symptoms and social impairment. They have been used to measure premenstrual symptom severity and response to treatment in several clinical trials and prevalence studies. Score ranges from no symptoms to severe symptoms on a scale of 0 to 6, with 0 being no symptoms and 6 being severely symptomatic.
Time Frame Every 2 weeks for 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.
Arm/Group Title Continuous Yasmin Interrupted Yasmin Continuous Yasmin Plus Progesterone Antagonist
Hide Arm/Group Description:
Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Clinical Global Impression Scale (CGI) Factors Associated With Premenstrual Symptoms.
Hide Description The CGI was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication.1 The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI actually comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale, with 1 being normal/more improved and 7 being severe/worse.
Time Frame Every 2 wks for 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.
Arm/Group Title Continuous Yasmin Interrupted Yasmin Continuous Yasmin Plus Progesterone Antagonist
Hide Arm/Group Description:
Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Beck Depression Inventory (BDI) Factors Associated With Premenstrual Symptoms
Time Frame Every 2 weeks for 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.
Arm/Group Title Continuous Yasmin Interrupted Yasmin Continuous Yasmin Plus Progesterone Antagonist
Hide Arm/Group Description:
Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous OCP Plus Placebo Interrupted OC Continuous OC Plus PR Antagonist
Hide Arm/Group Description Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle. Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo). Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
All-Cause Mortality
Continuous OCP Plus Placebo Interrupted OC Continuous OC Plus PR Antagonist
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Continuous OCP Plus Placebo Interrupted OC Continuous OC Plus PR Antagonist
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Continuous OCP Plus Placebo Interrupted OC Continuous OC Plus PR Antagonist
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%)   0/2 (0.00%) 
Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential CNS effect of the compound on behavior.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Pedro E. Martinez, M.D., Principal Investigator
Organization: Behavioral Endocrinology Branch/National Institute of Mental Health/NIH
Phone: 301-402-0615
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00089414     History of Changes
Other Study ID Numbers: 040221
04-M-0221
First Submitted: August 4, 2004
First Posted: August 5, 2004
Results First Submitted: January 14, 2013
Results First Posted: January 2, 2017
Last Update Posted: August 25, 2017