A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00394771
First received: October 30, 2006
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary


Condition Intervention Phase
Breakthrough Bleeding
Drug: DR-1031
Drug: Seasonale®
Drug: Portia®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]
    Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.

  • Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ] [ Designated as safety issue: No ]
    Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.


Secondary Outcome Measures:
  • Days With Bleeding During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]
    Bleeding is defined as a flow heavy enough to require sanitary protection.

  • Days With Bleeding During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ] [ Designated as safety issue: No ]
    Bleeding is defined as a flow heavy enough to require sanitary protection.

  • Time to First Bleeding Day [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]

    Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.

    Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding.


  • Maximum Bleeding Severity During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]

    Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.

    Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.

    See pre-specified analyses for Number of Moderate to Heavy Bleeding Days.


  • Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91) [ Time Frame: Day 85-91 ] [ Designated as safety issue: No ]
    Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.

  • Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183) [ Time Frame: Day 177-183 ] [ Designated as safety issue: No ]
    Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.

  • Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ] [ Designated as safety issue: Yes ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

  • Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ] [ Designated as safety issue: Yes ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

  • Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91) [ Time Frame: Day 85-91 ] [ Designated as safety issue: Yes ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

  • Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183) [ Time Frame: Day 177-183 ] [ Designated as safety issue: Yes ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.


Other Outcome Measures:
  • Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]
    Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.

  • Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ] [ Designated as safety issue: No ]
    Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.


Enrollment: 567
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose DR-1031
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
Drug: DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Other Names:
  • levonorgestrel/ethinyl estradiol
  • Quartette®
Drug: Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol
Experimental: Midrange Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
Drug: DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Other Names:
  • levonorgestrel/ethinyl estradiol
  • Quartette®
Drug: Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol
Experimental: High Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
Drug: DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Other Names:
  • levonorgestrel/ethinyl estradiol
  • Quartette®
Drug: Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol
Active Comparator: Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Drug: Seasonale®
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
Other Name: levonorgestrel/ethinyl estradiol
Drug: Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol

Detailed Description:

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Premenopausal
  • Not pregnant or breastfeeding
  • Agree to use back-up non-hormonal contraception for study period

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Pregnancy within the last 3 months
  • Smoking >10 cigarettes per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394771

  Show 50 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Principal Investigator: Duramed Medical Monitor Duramed Research
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00394771     History of Changes
Other Study ID Numbers: DR-ASC-201
Study First Received: October 30, 2006
Results First Received: April 25, 2013
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
oral contraceptives
breakthrough bleeding
spotting

Additional relevant MeSH terms:
Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on September 16, 2014