Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity
Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
Intervention: combined oral contraceptives (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Southern California
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.
Clinical Details
Official title: LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: follicle-stimulating hormone
Secondary outcome: lutenizing hormoneestradiol progesterone
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy, reproductive age women
- 18 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
Exclusion Criteria:
- 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)
Locations and Contacts
LAC and USC Medical Center, Los Angeles, California, United States
Additional Information
Last updated: September 25, 2013
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