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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


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 hormone




Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.


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


- 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

Page last updated: August 23, 2015

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