Trial Outcomes & Findings for Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity (NCT NCT01953211)

Results Overview

mean FSH on day 7 of the pill free interval

Recruitment status

COMPLETED

Target enrollment

64 participants

Primary outcome timeframe

Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.

Results posted on

2019-07-26

Participant Flow

clinic

voluntary

Participant milestones

Participant milestones
Measure	Healthy Reproductive Age Women These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months combined oral contraceptives
Overall Study STARTED	64
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Reproductive Age Women n=64 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28 years n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.

Population: 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

mean FSH on day 7 of the pill free interval

Outcome measures

Outcome measures
Measure	20 mcg EE n=21 Participants These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months	30 mcg EE n=21 Participants These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months	35 mcg EE n=20 Participants These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
Follicle-stimulating Hormone	5.01 milli international units per milliliter Standard Deviation 0.25	5.86 milli international units per milliliter Standard Deviation 0.55	6.38 milli international units per milliliter Standard Deviation 0.60

Adverse Events

Healthy Reproductive Age Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Cho

University Reproductive Associates

Phone: (201) 288-6330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place