Back to resultsA Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
Primary Purpose
Healthy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
Seasonique (LNG/EE and EE)
Portia (LNG/EE)
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility 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
Sites / Locations
- Duramed Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
Secondary Outcome Measures
Compare the differences in hormone withdrawal symptoms
Compare differences in ovarian follicular development
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00117273
Brief Title
A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Duramed Research
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
Intervention Description
1 tablet daily
Intervention Type
Drug
Intervention Name(s)
Seasonique (LNG/EE and EE)
Intervention Description
1 tablet daily
Intervention Type
Drug
Intervention Name(s)
Portia (LNG/EE)
Intervention Description
1 tablet daily x 28 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Compare the differences in hormone withdrawal symptoms
Time Frame
Before, during and after the 7-day hormone free interval or EE-supplemented interval
Title
Compare differences in ovarian follicular development
Time Frame
Before, during and after the 7-day hormone free interval or EE-supplemented intervals
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duramed Protocol Chair
Organizational Affiliation
Duramed Research, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Duramed Investigational Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mayoclinic.com/health/birth-control/BI99999
Description
Mayo Clinic - Birth Control Guide
Learn more about this trial
A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
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