NCT02367846View on ClinicalTrials.gov

Assessing the Impact of Contraceptives on Bone Health Using 41Ca

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Other Disorders of Bone Development and Growth
Interventions
DRUG

Combined Oral Contraceptive (COC)

The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral vs. non-oral ethinyl estradiol on net bone calcium balance. A prospective crossover study with repeated measures and a simple random assignment will be used to test the effects of 49 days of COC use on bone metabolism using 41Ca to determine net bone calcium balance. Subjects will be randomized to receive COC during either the first or second intervention period.

DRUG

Contraceptive Vaginal Ring (CVR)

The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral vs. non-oral ethinyl estradiol on net bone calcium balance. A prospective crossover study with repeated measures and a simple random assignment will be used to test the effects of 49 days of CVR use on bone metabolism using 41Ca to determine net bone calcium balance. Subjects will be randomized to receive CVR during either the first or second intervention period.

Trial Locations (1)

16802

Women's Health and Exercise Laboratories, The Pennsylvania State University, University Park

All Listed Sponsors
collaborator

Purdue University

OTHER

lead

Penn State University

OTHER