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

NCT00196313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2016-09-22

Study results available
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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.

Conditions

  • Dysmenorrhea

Interventions

DRUG

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets

1 tablet daily by mouth

DRUG

Placebo tablet

1 tablet daily by mouth

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00196313 on ClinicalTrials.gov