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

NCT00196365 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2014-05-12

No results posted yet for this study

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

  • Dysmenorrhea

Interventions

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

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Principal Investigators

  • Duramed Protocol Chair · Duramed Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-07-31
Completion
2007-07-31

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 NCT00196365 on ClinicalTrials.gov