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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 23, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in the clinical assessment of dysmenorrhea [ Time Frame: Baseline to Week 4,8,12,24, and 26 or early discontinuation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in the clinical assessment of dysmenorrhea

Change History

Complete list of historical versions of study NCT00196365 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms) [ Time Frame: Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation ] [ Designated as safety issue: No ]
Incidence of menstrual bleeding and/or spotting [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Analgesic use [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in clinical assessment of dysmenorrheal at weeks 4, 8, 12, 24 and 26 visits
Incidence of menstrual bleeding and/or spotting
Analgesic use

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Dysmenorrhea

Intervention ^ICMJE

Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Moderate to severe menstrual-related pain
Regular spontaneous menstrual cycles

Exclusion Criteria:

Any contraindication to the use of oral contraceptives
Treatment with an oral contraceptive in the last 3 months
Previous treatment failure with an extended oral contraceptive regimen

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00196365

Responsible Party

Duramed Protocol Chair, Duramed Research, Inc.

Study ID Numbers ^ICMJE

DR-PSE-305

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

Information Provided By

Duramed Research

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP