A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale. - Tabular View

Tracking Information

First Received Date ^ICMJE

October 30, 2006

Last Updated Date

July 23, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total number of bleeding and/or spotting days during active treatment period. [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Total number of bleeding and/or spotting days during active treatment period.

Change History

Complete list of historical versions of study NCT00394771 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Total number of bleeding days during active treatment period [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Timing and severity of bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Onset,duration,severity of scheduled withdrawal bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Number of subjects reporting hormone-related symptoms [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Adverse events reported by subjects and investigators [ Time Frame: Active treatment period ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Total number of bleeding days during active treatment period
Timing and severity of bleeding
Onset,duration,severity of scheduled withdrawal bleeding
Number of subjects reporting hormone-related symptoms
Adverse events reported by subjects and investigators

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale.

Official Title ^ICMJE

A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen

Brief Summary

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary

Detailed Description

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Breakthrough Bleeding

Intervention ^ICMJE

Drug: DR-1031a
Drug: DR-1031b
Drug: DR-1031c
Drug: Seasonale

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

Estimated Enrollment ^ICMJE

400

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Premenopausal
Not pregnant or breastfeeding
Agree to use back-up non-hormonal contraception for study period

Exclusion Criteria:

Any contraindication to the use of oral contraceptives
Pregnancy within the last 3 months
Smoking >10 cigarettes per day

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00394771

Responsible Party

Duramed Research, Duramed Research, Inc

Study ID Numbers ^ICMJE

DR-ASC-201

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Duramed Medical Monitor

Duramed Research

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