A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 4/21/2016 |
| Start Date: | May 2005 |
| End Date: | October 2008 |
A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents
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 13 weeks of treatment with the option
to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9
months. Patients will be required to record menstrual pain in a daily diary.
extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the
typical hormone-free interval. Patients will receive 13 weeks of treatment with the option
to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9
months. Patients will be required to record menstrual pain in a daily diary.
Inclusion Criteria:
- Sexually naïve and agree to abstain from sex during the study
- Moderate to severe menstrual-related pelvic pain
- Regular spontaneous menstrual cycles
Exclusion Criteria:
- Any contraindication to the use of oral contraceptives
- Treatment with an oral contraceptive within the previous 3 months
- Previous treatment failure with an extended oral contraceptive regimen
We found this trial at
13
sites
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