Trials / Completed
CompletedNCT00196365
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- Duramed Research · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets | 1 tablet daily |
| DRUG | levonorgestrel/EE 0.15/0.03 mg tablets and placebo | 1 tablet daily |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2005-09-20
- Last updated
- 2014-05-12
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00196365. Inclusion in this directory is not an endorsement.