Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT01953211
• Collaborator: (none)
• Enrollment: 64
• Location: 1

Study Details

Study Description

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	Phase
Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy	Drug: combined oral contraceptives

Study Design

• 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: Dec 1, 1998

Arms and Interventions

Arm	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 Names: ALESSE, LOESTRIN, NORDETTE, ORTHOCEPT, ORTHOCYCLEN, ORTHO NOVUM

Outcome Measures

Primary Outcome Measures

1. Follicle-stimulating Hormone [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAC and USC Medical Center	Los Angeles	California	United States

Sponsors and Collaborators

• University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank Stanczyk, Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT01953211
• Other Study ID Numbers: Hormone free interval
• First Posted: Sep 30, 2013
• Last Update Posted: Jul 26, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Pituitary Diseases; Contraceptive Agents; Norinyl; Contraceptives, Oral; Contraceptives, Oral, Combined

Study Results

Participant Flow

Recruitment Details	clinic
Pre-assignment Detail	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
COMPLETED	64
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Healthy Reproductive Age Women
Arm/Group Description
Overall Participants	64
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	64 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	28
Sex: Female, Male (Count of Participants)
Female	64 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	64 100%

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
Measure Participants	21	21	20
Mean (Standard Deviation) [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
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.02
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.57
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	30 mcg EE
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.63
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.9
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	35 mcg EE
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.83
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.78
	Estimation Comments

Adverse Events

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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Healthy Reproductive Age Women
	Affected / at Risk (%)	# Events
Total	0/64 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Reproductive Age Women
	Affected / at Risk (%)	# Events
Total	0/64 (0%)

Limitations/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.