Phase 2
Completed N=95
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Source: ClinicalTrials.gov NCT00196313 ↗Enrolled (actual)
95
Serious AEs
2.1%
Results posted
May 2012
Primary outcomePrimary: Mean Change in Average Severity for Abdominal/Pelvic Pain — -0.45; -0.19 units on a scale
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Average Severity for Abdominal/Pelvic Pain |
-0.45; -0.19 | — |
| SECONDARY Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain |
-0.62; -0.17 | — |
| SECONDARY Incidence of Menstrual Bleeding and /or Spotting |
28.389; 18.000 | — |
| SECONDARY Number of Days Missed From School/Work or Other Activities |
0.83; 2.75 | — |
| SECONDARY Analgesic Use |
2.92; 4.03 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00196313). 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. Informational only — not medical advice.