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Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

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ClinicalTrials.gov Identifier: NCT01953211
Recruitment Status : Completed
First Posted : September 30, 2013
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Frank Stanczyk, 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.

Condition or disease Intervention/treatment
Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy Drug: combined oral contraceptives

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens
Actual Primary Completion Date : December 1998

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy reproductive age women
These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
Drug: combined oral contraceptives
Other Name: ALESSE, LOESTRIN, NORDETTE, ORTHOCEPT, ORTHOCYCLEN, ORTHO NOVUM




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
Healthy, reproductive age women 18 to 35 years old, who were seeking contraception from the general gynecology clinics of the LAC and USC Medical Center were recruited. The research team identified potential candidates who were taking one of 6 possible monophasic COC formulations. Informed consent was obtained from participants by the research staff. To be eligible for participation, women reported regular menstrual cycles prior to COCs, and had taken at least 3 cycles of the same monophasic COC prior to enrollment.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953211


Locations
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United States, California
LAC and USC Medical Center
Los Angeles, California, United States
Sponsors and Collaborators
University of Southern California
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Responsible Party: Frank Stanczyk, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01953211    
Other Study ID Numbers: Hormone free interval
First Posted: September 30, 2013    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Contraceptive Agents
Norinyl
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptive Agents, Hormonal