Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity
LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens
1 other identifier
observational
64
1 country
1
Brief Summary
The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (COC) hormone users varies depending on the dose of ethinyl estradiol in the formulation. This variation in activation may be associated with different side effects during the hormone free interval. Progesterone (P) remained suppressed during all 6 COC regimens (\<1.8 ng/mL), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
December 1, 1998
CompletedFirst Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedResults Posted
Study results publicly available
July 26, 2019
CompletedJuly 26, 2019
July 1, 2019
September 17, 2013
July 19, 2015
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Follicle-stimulating Hormone
mean FSH on day 7 of the pill free interval
Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.
Study Arms (1)
Healthy reproductive age women
These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
Interventions
Eligibility Criteria
Healthy, reproductive age women 18 to 35 years old, who were seeking contraception from the general gynecology clinics of the LAC and USC Medical Center were recruited. The research team identified potential candidates who were taking one of 6 possible monophasic COC formulations. Informed consent was obtained from participants by the research staff. To be eligible for participation, women reported regular menstrual cycles prior to COCs, and had taken at least 3 cycles of the same monophasic COC prior to enrollment.
You may qualify if:
- Healthy, reproductive age women
- to 35 years old,
- seeking contraception from the general gynecology clinics of the LAC and USC Medical Center w
- taking one of 6 possible monophasic COC formulations for at least 3 cycles prior to enrollment
- regular menstrual cycles prior to COCs
You may not qualify if:
- Irregular bleeding
- bilateral oophorectomy
- amenorrhea
- hormone-sensitive cancer
- concurrent medications known to interfere with steroid metabolism (i.e., barbiturates, phenytoin, carbamazepine, ethosuximide, primidone, rifampin, tetracycline)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LAC and USC Medical Center
Los Angeles, California, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Cho
- Organization
- University Reproductive Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 30, 2013
Primary Completion
December 1, 1998
Last Updated
July 26, 2019
Results First Posted
July 26, 2019
Record last verified: 2019-07