How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills

NCT03418363 | Completed Phase 4

• 1 other identifier: OHSU IRB# 17651
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral contraceptives; Venous thromboembolism; androgenic combined oral contraception

Outcome Measures

Primary Outcomes (6)

• Change in 3-month plasma levels of APC-r

  Access change in blood levels from baseline (Visit 1) to study completion visit (Visit 2). Collection of whole blood samples from participants to assess change in levels of APC-r after randomization to DHEA supplementation or placebo for 3 cycles (approximately 3 months).

  Baseline & Study Completion (month 3)

• Change in 3-month plasma levels of protein S

  Access change in blood levels from baseline (Visit 1) to study completion visit (Visit 2). Collection of whole blood samples from participants to assess change in levels of protein S after randomization to DHEA supplementation or placebo for 3 cycles (approximately 3 months).

  Baseline & Study Completion (month 3)

• Change in 3-month serum levels of SHBG

  Access change in blood levels from baseline (Visit 1) to study completion visit (Visit 2). Collection of whole blood samples from participants to assess change in levels of SHBG after randomization to DHEA supplementation or placebo for 3 cycles (approximately 3 months).

  Baseline & Study Completion (month 3)

• Change in 3-month serum levels of ethinyl estradiol

  Access change in blood levels from baseline (Visit 1) to study completion visit (Visit 2). Collection of whole blood samples from participants to assess change in levels of ethinyl estradiol after randomization to DHEA supplementation or placebo for 3 cycles (approximately 3 months).

  Baseline & Study Completion (month 3)

• Change in 3-month serum levels of DHEA

  Access change in blood levels from baseline (Visit 1) to study completion visit (Visit 2). Collection of whole blood samples from participants to assess change in levels of DHEA after randomization to DHEA supplementation or placebo for 3 cycles (approximately 3 months).

  Baseline & Study Completion (month 3)

• Change in 3-month serum levels of free and total testosterone

  Access change in blood levels from baseline (Visit 1) to study completion visit (Visit 2). Collection of whole blood samples from participants to assess change in levels of total testosterone and free testosterone (calculated using serum albumin) after randomization to DHEA supplementation or placebo for 3 cycles (approximately 3 months).

  Baseline & Study Completion (month 3)

Study Arms (2)

DHEA Oral Capsule

ACTIVE COMPARATOR

Subjects will take 100mg DHEA (dehydroepiandrosterone) daily

Dietary Supplement: DHEA Oral Capsule

Placebo Oral Capsule

PLACEBO COMPARATOR

Other: Placebo Oral Capsule

Interventions

DHEA Oral Capsule DIETARY_SUPPLEMENT

Daily 100mg DHEA supplement

DHEA Oral Capsule

Placebo Oral Capsule OTHER

Daily oral capsule

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women of reproductive age (18-44 years) in generally good health and with body mass index (BMI) between 18 and 35kg/m2
• Premenopausal, with uterus and at least one ovary intact
• Current users (at least 3 months) of combined oral contraception consisting of 0.02 mg (milligram) ethinyl estradiol and 3 mg drospirenone
• Willing to continue use of current combined oral contraception for the next three menstrual cycles
• Have a prescription for combined oral contraception consisting of ethinyl estradiol and drospirenone for the next four cycles
• Not currently using androgen supplementation
• Willing and able to sign the informed consent
• Willing to comply with the study requirements and visit schedule
• No desire to conceive during study participation, approximately 3 months

You may not qualify if:

• Currently enrolled in another clinical trial
• Contraindications to androgen supplementation; history of polycystic ovarian syndrome (PCOS)
• Known or suspected pregnancy, pregnancy within 3 months before study enrollment, or desire to conceive during study participation
• Currently breastfeeding
• Known or suspected alcoholism or drug abuse

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Contraception Behavior; Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Study Officials

• Jeffrey Jensen, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: February 1, 2018
• Study Start: January 16, 2018
• Primary Completion: March 11, 2019
• Study Completion: December 11, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

US (1)