A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills
1 other identifier
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 healthy
Started Jun 2005
Typical duration for phase_3 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 6, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMay 9, 2014
May 1, 2014
June 30, 2005
May 8, 2014
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (2)
Compare the differences in hormone withdrawal symptoms
Before, during and after the 7-day hormone free interval or EE-supplemented interval
Compare differences in ovarian follicular development
Before, during and after the 7-day hormone free interval or EE-supplemented intervals
Study Arms (3)
1
EXPERIMENTAL2
ACTIVE COMPARATOR3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Premenopausal
- Not pregnant or breastfeeding
- Weight \<200 lbs
- Currently taking oral contraceptives in the standard 28-day regimen for at least two months
You may not qualify if:
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking \> 10 cigarettes per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (1)
Duramed Investigational Site
Temple, Texas, 76508, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duramed Protocol Chair
Duramed Research, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 6, 2005
Study Start
June 1, 2005
Study Completion
June 1, 2006
Last Updated
May 9, 2014
Record last verified: 2014-05