Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

University of Southern California

Status: Completed

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

Treatments: Drug: combined oral contraceptives

Study type: Observational

Funder types: Other

Identifiers

NCT01953211

Hormone free interval

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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)

Trial design

64 participants in 1 patient group

Healthy reproductive age women

Description:

These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months

Treatment:

Drug: combined oral contraceptives