A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens - Full Text View

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00117273

Purpose

This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).

Condition	Intervention	Phase
Healthy	Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] Drug: Seasonique (LNG/EE and EE) Drug: Portia (LNG/EE)	Phase III

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol) [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the differences in hormone withdrawal symptoms [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented interval ] [ Designated as safety issue: No ]
Compare differences in ovarian follicular development [ Time Frame: Before, during and after the 7-day hormone free interval or EE-supplemented intervals ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2006

Arms	Assigned Interventions
1: Experimental	Drug: Seasonique (LNG/EE and EE) 1 tablet daily
2: Active Comparator	Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] 1 tablet daily
3: Active Comparator	Drug: Portia (LNG/EE) 1 tablet daily x 28 days

Eligibility

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

Criteria

Inclusion Criteria:

Premenopausal
Not pregnant or breastfeeding
Weight <200 lbs
Currently taking oral contraceptives in the standard 28-day regimen for at least two months

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117273

Locations

United States, Texas
Duramed Investigational Site
Temple, Texas, United States, 76508

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

Mayo Clinic - Birth Control Guide This link exits the ClinicalTrials.gov site

Responsible Party:	Duramed Research, Inc. ( Duramed Protocol Chair )
Study ID Numbers:	DR PSE 310
Study First Received:	June 30, 2005
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00117273
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Levonorgestrel
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol

Estradiol 17 beta-cypionate
Healthy
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009