Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

• 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: University of Southern California
• Information provided by (Responsible Party): Frank Stanczyk, University of Southern California

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Condition: Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
• Intervention: Drug: combined oral contraceptives
• Enrollment: 64

Participant Flow

Recruitment Details	clinic
Pre-assignment Details	voluntary

Arm/Group Title	Healthy Reproductive Age Women
Arm/Group Description	These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months combined oral contraceptives
Period Title: Overall Study
Started	64 [1]
Completed	64 [1]
Not Completed	0
[1] completed prior to clinical trials submission

Baseline Characteristics

Arm/Group Title		Healthy Reproductive Age Women
Arm/Group Description		[Not Specified]
Overall Number of Baseline Participants		64
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	64 100.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	64 participants
		28; (18 to 35)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	64 participants
	Female	64 100.0%
	Male	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	64 participants
		64

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Of note 1 person from the 20 and another from the 30 mcg EE groups hand significant loss of sample and poor processing due to limitations with processing and transport. As a result of this not all participants were able to contribute data for analysis

Arm/Group Title	20 mcg EE	30 mcg EE	35 mcg EE
Arm/Group Description:	These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months	These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months	These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
Overall Number of Participants Analyzed	21	21	20
Mean (Standard Deviation); Unit of Measure: milli international units per milliliter
	5.01 (0.25)	5.86 (0.55)	6.38 (0.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20 mcg EE
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.88
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.02
	Parameter Dispersion	Type: Standard Deviation; Value: 0.57
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	30 mcg EE
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.63
	Parameter Dispersion	Type: Standard Deviation; Value: 0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	35 mcg EE
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.83
	Parameter Dispersion	Type: Standard Deviation; Value: 0.78
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Healthy Reproductive Age Women
Arm/Group Description	These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months combined oral contraceptives
All-Cause Mortality
	Healthy Reproductive Age Women
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Healthy Reproductive Age Women
	Affected / at Risk (%)
Total	0/64 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Healthy Reproductive Age Women
	Affected / at Risk (%)
Total	0/64 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Michael Cho
• Organization: University Reproductive Associates
• Phone: (201) 288-6330
• EMail: michaelcho@nyc.com

• Responsible Party: Frank Stanczyk, University of Southern California
• ClinicalTrials.gov Identifier: NCT01953211
• Other Study ID Numbers: Hormone free interval
• First Submitted: September 17, 2013
• First Posted: September 30, 2013
• Results First Submitted: July 19, 2015
• Results First Posted: July 26, 2019
• Last Update Posted: July 26, 2019