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

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: DR-1021 Drug: Desogestrel 150mcg /Ethinyl Estradiol (EE) 20mcg-10mcg EE	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021

Resource links provided by NLM:

Drug Information available for: Estradiol Ethinyl Estradiol Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate Desogestrel

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	October 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: DR-1021 1 tablet daily
Active Comparator: 2	Drug: Desogestrel 150mcg /Ethinyl Estradiol (EE) 20mcg-10mcg EE 1 tablet daily

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544882

Locations

United States, New Jersey
Duramed Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, Ohio
Duramed Investigational Site
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Duramed Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, Washington
Duramed Investigational Site
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

No publications provided

Responsible Party:	Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier:	NCT00544882 History of Changes
Other Study ID Numbers:	DR-DSG-302
Study First Received:	October 12, 2007
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Contraceptives, Oral
Desogestrel
Estradiol
Ethinyl Estradiol
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Progestins
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 16, 2013