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How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills

NCT03418363 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-23

No results posted yet for this study

Summary

A randomized study is to learn more about how a supplement called DHEA (dehydroepiandrosterone) affects clotting factors in women taking combined oral contraceptive pills. Current research suggests that the progestin hormone in a specific type of birth control pill may increase a woman's blood clot risk. However, it is unknown exactly how the progestin causes the increased risk. This study aims to learn if taking a daily dose of supplemental androgen (dehydroepiandrosterone, or DHEA) in addition to birth control pills containing DRSP affects proteins related to coagulation.

Conditions

  • Contraceptive Usage
  • Coagulation

Interventions

DIETARY_SUPPLEMENT

DHEA Oral Capsule

Daily 100mg DHEA supplement

OTHER

Placebo Oral Capsule

Daily oral capsule

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jeffrey Jensen, MD, MPH · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2019-03-11
Completion
2019-12-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418363 on ClinicalTrials.gov