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Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 17, 2013
First Posted Date September 30, 2013
Results First Submitted Date July 19, 2015
Results First Posted Date July 26, 2019
Last Update Posted Date July 26, 2019
Study Start Date Not Provided
Actual Primary Completion Date December 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2019)		 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
Original Primary Outcome Measures
 (submitted: September 25, 2013)		 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 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: September 25, 2013)
  • lutenizing hormone [ Time Frame: daily serum during the hormone free interval ]
  • estradiol [ Time Frame: daily serum samples during the hormone free interval ]
  • progesterone [ Time Frame: daily serum during the 7 day hormone free interval ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity
Official Title LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
Intervention Drug: combined oral contraceptives
Other Name: ALESSE, LOESTRIN, NORDETTE, ORTHOCEPT, ORTHOCYCLEN, ORTHO NOVUM
Study Groups/Cohorts Healthy reproductive age women
These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
Intervention: Drug: combined oral contraceptives
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2019)		 64
Original Enrollment Not Provided
Study Completion Date Not Provided
Actual Primary Completion Date December 1998   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01953211
Other Study ID Numbers Hormone free interval
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Frank Stanczyk, University of Southern California
Original Responsible Party Same as current
Current Study Sponsor University of Southern California
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Southern California
Verification Date July 2019