Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

NCT ID: NCT01953211

Last Updated: 2019-07-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy reproductive age women

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

combined oral contraceptives

Intervention Type DRUG

Interventions

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combined oral contraceptives

Intervention Type DRUG

Other Intervention Names

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ALESSE, LOESTRIN, NORDETTE, ORTHOCEPT, ORTHOCYCLEN, ORTHO NOVUM

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Frank Stanczyk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LAC and USC Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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Hormone free interval

Identifier Type: -

Identifier Source: org_study_id

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