Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

Completed

Conditions studied: Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy

In brief

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.

Key facts

Study ID

NCT01953211

Run by

University of Southern California

People needed

64

Last updated by the study team

2019-07-26

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

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)

Where it is running

• LAC and USC Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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