A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021 - Tabular View

Tracking Information

First Received Date ^ICMJE

October 12, 2007

Last Updated Date

July 23, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Compare differences in hormone patterns (follicle stimulating hormone [FSH], inhibin-B, and estradiol)and ovarian follicular development [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Compare differences in hormone patterns (follicle stimulating hormone [FSH], inhibin-B, and estradiol)and ovarian follicular development

Change History

Complete list of historical versions of study NCT00544882 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Analyze bleeding patterns [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Analyze bleeding patterns

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

Official Title ^ICMJE

A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021

Brief Summary

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021. Study duration will be approximately 12-20 weeks including a screening period, a 28-day baseline cycle, a 28-day randomized cycle, and a 21-day follow-up cycle. Participants will receive one of two treatments (either Mircette oral contraceptive or DR-1021). Participants will have blood draws and transvaginal ultrasounds at clinic visits and be asked to complete a data diary.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: DR-1021
Drug: Desogestrel 150mcg /Ethinyl Estradiol (EE) 20mcg-10mcg EE

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

Completion Date

March 2008

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Premenopausal
Weight <200 lbs
Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
Others as dictated by protocol

Exclusion Criteria:

Any contraindication to the use of oral contraceptives
Breast feeding
Smoking > 10 cigarettes per day
Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])
Others as dictated by protocol

Gender

Female

Ages

18 Years to 35 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

NCT00544882

Responsible Party

Duramed Protocol Chair, Duramed Research, Inc.

Study ID Numbers ^ICMJE

DR-DSG-302

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