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Trial record 61 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills (COC+DHEA)

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ClinicalTrials.gov Identifier: NCT03418363
Recruitment Status : Active, not recruiting
First Posted : February 1, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE February 1, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE January 16, 2018
Actual Primary Completion Date March 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • Change in 3-month plasma levels of APC-r [ Time Frame: Study Completion (month 3) ]
    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).
  • Change in 3-month plasma levels of protein S [ Time Frame: Study Completion (month 3) ]
    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).
  • Change in 3-month serum levels of SHBG [ Time Frame: Study Completion (month 3) ]
    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).
  • Change in 3-month serum levels of ethinyl estradiol [ Time Frame: Study Completion (month 3) ]
    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).
  • Change in 3-month serum levels of DHEA [ Time Frame: Study Completion (month 3) ]
    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).
  • Change in 3-month serum levels of free and total testosterone [ Time Frame: Study Completion (month 3) ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03418363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills
Official Title  ICMJE Effect of the Addition of an Oral Androgen (Dehydroepiandrosterone) on Hepatic Globulins in Users of an Antiandrogenic Combined Oral Contraceptive (Ethinyl Estradiol/Drospirenone)
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.
Detailed Description

While the pro-thrombotic effects of estrogens are well established in women using combined oral contraception (COC), controversy exists over whether the various synthetic progestogens (progestins) used in combination with ethinyl estradiol in COC formulations may modify the risk of venous thromboembolism (VTE). Several studies have demonstrated that different types of progestins used in COCs influence the magnitude of the estrogen-induced changes in coagulation pathway proteins. However, since hepatocytes do not express progesterone receptor, any activity of a progestin must be indirect. While all progestins on the market are strong agonists for the progesterone receptor (PR), most have variable affinity for the androgen receptor (AR), glucocorticoid receptor (GR), and mineralocorticoid receptor (MR). Generations of progestins have been developed, each successive generation exhibiting decreasing levels of androgenicity. Recent epidemiologic studies have suggested an increased risk of VTE in women using low-androgen progestins relative to those using levonorgestrel-containing products. Although no pattern of hepatic globulin changes has been validated as a surrogate marker for thrombosis risk, the overall magnitude of change in various hepatic proteins involved in coagulation is greater with the newer low-androgenic progestins compared to levonorgestrel, leading some experts to suggest that a progestin's androgenic profile may influence the risk of thrombosis. However, a series of well-designed large prospective cohort studies have not confirmed the increased risk of VTE with low-androgen progestins.

A major problem with reconciling the conflicting results from epidemiologic and prospective studies has been the lack of a clear mechanism, as no studies have demonstrated whether these observed changes are mediated through androgen receptor activity. We hypothesize that androgen receptor activity opposes the estrogen receptor-mediated increase in hepatic clotting factors in women using combined oral contraceptives. To test this hypothesis, we propose a randomized clinical trial in which we will enroll healthy women using combined oral contraception containing ethinyl estradiol (EE) with an antiandrogenic progestin (drospirenone, DRSP). Participants will be randomized to treatment with oral androgen (dehydroepiandrosterone, DHEA) or placebo, and we will collect whole blood samples to measure coagulation pathway-related hepatic globulins (APC-r, Protein S, SHBG) before and after treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose: Basic Science
Condition  ICMJE
  • Contraceptive Usage
  • Coagulation
Intervention  ICMJE
  • Dietary Supplement: DHEA Oral Capsule
    Daily 100mg DHEA supplement
  • Other: Placebo Oral Capsule
    Daily oral capsule
Study Arms  ICMJE
  • Active Comparator: DHEA Oral Capsule
    Subjects will take 100mg DHEA (dehydroepiandrosterone) daily
    Intervention: Dietary Supplement: DHEA Oral Capsule
  • Placebo Comparator: Placebo Oral Capsule
    Intervention: Other: Placebo Oral Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Actual Primary Completion Date March 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418363
Other Study ID Numbers  ICMJE OHSU IRB# 17651
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Jensen, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Jensen, MD, MPH Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP