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OpenTrials
Completed

NCT Number: NCT01953211

Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

LAC and USC Medical Center

Los Angeles, California, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Combined oral contraceptives

Drug

Other names: ALESSE, LOESTRIN, NORDETTE, ORTHOCEPT, ORTHOCYCLEN, ORTHO NOVUM

Primary outcomes

  1. Follicle-stimulating Hormone

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens

Important dates

Primary completion
1998
First posted
Sep 30, 2013
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.