Phase 2
N=567
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Breakthrough Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT00394771 ↗Enrolled (actual)
567
Serious AEs
1.9%
Results posted
Jun 2013
Primary outcome: Primary: Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) — 13; 13.5; 15; 15 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DR-1031 (Drug); Seasonale® (Drug); Portia® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duramed Research
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) |
13; 13.5; 15; 15 | — |
| PRIMARY Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176) |
6; 7; 5; 6 | — |
| SECONDARY Days With Bleeding During Active Cycle 1 (Day 1-84) |
3.5; 2.5; 4; 2 | — |
| SECONDARY Days With Bleeding During Active Cycle 2 (Day 92-176) |
1; 2; 1; 2 | — |
| SECONDARY Time to First Bleeding Day |
— | — |
| SECONDARY Maximum Bleeding Severity During Active Cycle 1 (Day 1-84) |
— | — |
| SECONDARY Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91) |
14; 28; 25; 27; 36; 17 | — |
| SECONDARY Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183) |
15; 20; 23; 21; 32; 32 | — |
| SECONDARY Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84) |
58; 57; 50; 64; 83; 84 | — |
| SECONDARY Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176) |
46; 47; 44; 44; 74; 72 | — |
| SECONDARY Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91) |
33; 28; 17; 33; 57; 50 | — |
| SECONDARY Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183) |
29; 25; 15; 25; 39; 42 | — |
Summary
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00394771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.