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ACTIVE NOT RECRUITING
NCT02367846
PHASE4

Assessing the Impact of Contraceptives on Bone Health Using 41Ca

Sponsor: Penn State University

View on ClinicalTrials.gov

Summary

This preclinical randomized crossover study will examine the effects of oral versus non-oral contraceptive therapy on bone turnover in young exercising women. In an effort to expose the route-dependent effects of oral versus non-oral contraceptive therapy on bone turnover, the investigators will examine 1) the effects of ethinyl estradiol on bone calcium balance using the 41Ca technology and 2) the underlying physiological mechanisms associated with the effects of oral versus non-oral contraceptive therapy on net bone calcium balance.

Official title: The Effect of Oral vs. Non-oral Contraceptive Therapy on Bone Turnover Using 41Ca Methodology

Key Details

Gender

FEMALE

Age Range

18 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2015-01

Completion Date

2026-12

Last Updated

2025-05-13

Healthy Volunteers

Yes

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.

Locations (1)

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

University Park, Pennsylvania, United States