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

• Sponsor: Duramed Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00117273
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]; Drug: Seasonique (LNG/EE and EE); Drug: Portia (LNG/EE)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2005
• Study Completion Date: Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Seasonique (LNG/EE and EE); 1 tablet daily
Active Comparator: 2	Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]; 1 tablet daily
Active Comparator: 3	Drug: Portia (LNG/EE); 1 tablet daily x 28 days

Outcome Measures

Primary Outcome Measures

1. Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol) [Before, during and after the 7-day hormone free interval or EE-supplemented interval]

Secondary Outcome Measures

1. Compare the differences in hormone withdrawal symptoms [Before, during and after the 7-day hormone free interval or EE-supplemented interval]

2. Compare differences in ovarian follicular development [Before, during and after the 7-day hormone free interval or EE-supplemented intervals]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Duramed Investigational Site	Temple	Texas	United States	76508

Sponsors and Collaborators

• Duramed Research

Investigators

• Study Chair: Duramed Protocol Chair, Duramed Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic - Birth Control Guide

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00117273
• Other Study ID Numbers: DR PSE 310
• First Posted: Jul 6, 2005
• Last Update Posted: May 9, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Pituitary Diseases; Levonorgestrel; Ethinyl Estradiol; Estradiol

Study Results

No Results Posted as of May 9, 2014