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Completed

NCT Number: NCT00394771

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

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

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Key information

Conditions

Breakthrough Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Duramed Investigational Site, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR-1031

Drug

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®

Seasonale®

Drug

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 names: levonorgestrel/ethinyl estradiol

Portia®

Drug

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 names: levonorgestrel/ethinyl estradiol

Primary outcomes

  1. Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)

    Time frame: Day 1-84

    Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.

  2. Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)

    Time frame: Day 92-176

    Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.

Secondary outcomes

  1. Days With Bleeding During Active Cycle 1 (Day 1-84)

    Time frame: Day 1-84

    Bleeding is defined as a flow heavy enough to require sanitary protection.

  2. Days With Bleeding During Active Cycle 2 (Day 92-176)

    Time frame: Day 92-176

    Bleeding is defined as a flow heavy enough to require sanitary protection.

  3. Time to First Bleeding Day

    Time frame: Day 1-84

    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.

  4. Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)

    Time frame: Day 1-84

    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.

  5. Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)

    Time frame: Day 85-91

    Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.

  6. Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)

    Time frame: Day 177-183

    Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.

  7. Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)

    Time frame: Day 1-84

    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

  8. Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)

    Time frame: Day 92-176

    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

  9. Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)

    Time frame: Day 85-91

    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

  10. Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)

    Time frame: Day 177-183

    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

Other outcomes

  1. Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)

    Time frame: Day 1-84

    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.

  2. Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)

    Time frame: Day 92-176

    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.

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 1, 2006
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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