Phase 2 N=95 Randomized Double-blind Treatment

A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

Dysmenorrhea

Bottom Line

View on ClinicalTrials.gov: NCT00196313 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

May 2012

Primary outcome: Primary: Mean Change in Average Severity for Abdominal/Pelvic Pain — -0.45; -0.19 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets (Drug); Placebo tablet (Drug)
Age: Pediatric
Sex: Female
Sponsor: Duramed Research
Primary completion: Oct 2008

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	—

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.

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

View full record on ClinicalTrials.gov →

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.