Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

Completed

• Conditions: Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
• Interventions: Drug: combined oral contraceptives

• Registration Number: NCT01953211
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Primary Completion: 1998-12
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Results First Submitted: 2015-07-19
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Results First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy reproductive age women	combined oral contraceptives	These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months

Primary Outcome Measures

Name	Time	Method
Follicle-stimulating Hormone	Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.	mean FSH on day 7 of the pill free interval

Trial Locations

Locations (1)

LAC and USC Medical Center; 🇺🇸 Los Angeles, California, United States