Recruiting
Phase 4

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06264882

Conditions

Menopause

Estrogen Deficiency

Aging

Adiposity

Eligibility Criteria

Sex: Female

Age: 20 - 45

Healthy Volunteers: Accepted

Interventions

Degarelix

Transdermal Estradiol Patch

Transdermal Placebo Patch

Study Details

Brief summary:

The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen.

Conditions

Menopause

Estrogen Deficiency

Aging

Adiposity

Study ID

NCT06264882

Start date

Jun 1, 2024

Status verified date

Jun, 2024

Completion date

Aug 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age criteria of 20-45 years: the investigators are determining the effects of ovarian suppression on adiposity and vascular in premenopausal women;
  • Premenopausal defined as normal menstrual cycle function defined as no more than 1 missed cycle in the previous year: irregular menstrual or missed menstrual cycles could indicate that women are anovulatory and/or perimenopause;
  • Not pregnant or planning to become pregnant;
  • Not lactating in the last 3 months;
  • Serum FSH <10 IU/L measured during days 1-10 of the menstrual cycle: to ensure the woman is premenopausal and not perimenopausal;
  • Not on hormonal contraception in the last 3 months;
  • Sedentary or recreationally active (<2 days/wk vigorous exercise);
  • No use of medications that might influence vascular function (i.e., antihypertensives, lipid lowering medications, blood thinners);
  • No use of antioxidant supplements or chronic NSAIDs or be willing to go off them for 4 weeks prior to enrollment in the study;

Exclusion Criteria:

  • Diabetic or fasted glucose >126 mg/dL;
  • Body mass index (BMI) >35 kg/m2;
  • Weight change >5 kg in the last 3 months;
  • Use of glucocorticoids (inhaled, oral, topical) or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) in the last 3 months;
  • Excess alcohol consumption, defined as >14 drinks per week by self-report;
  • Known hypersensitivity to study medications;
  • Depressive symptoms, defined as a CES-D score >16;
  • Resting blood pressure >150/90 mmHg;
  • Preexisting or active cardiac, renal, or hepatic disease: past or current history of these diseases or conditions;
  • Active or chronic infection: inflammation associated with active or chronic infections impair vascular function;
  • Thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be reconsidered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
  • Smoking or Tobacco use within the previous 12 months;
  • Severe low bone mass or osteoporosis, defined as a hip or lumbar spine T-score <-2.0: safety reasons, women who are randomized to the ovarian suppression plus placebo group could see a decrease in bone mineral density due to the suppression of estrogen;
  • History of venous thromboembolic event (VTE): safety reasons, estradiol therapy can increase the risk of VTE;
  • History of breast cancer or other estrogen-dependent neoplasm: estradiol therapy is contraindicated;

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Degarelix plus transdermal placebo

At baseline \& 10 weeks: 80-mg subcutaneous injection of degarelix acetate plus Placebo transdermal patch (applied twice per week)

experimental: Degarelix plus transdermal estradiol

At baseline \& 10 weeks: 80-mg subcutaneous injection of degarelix acetate plus 0.075mg estradiol transdermal patch (applied twice per week)

Interventions

Degarelix

After first undergoing a pregnancy test, a clinician will administer an 80-mg subcutaneous injection of degarelix acetate (20 mg/mL; Ferring Pharmaceuticals Inc, Parsippany, NJ) to the women. A second injection will occur at 10 weeks. Compliance to the intervention will be ensured by having participants receive injections in the Clinical and Translational Research Center (CTRC), where all study visits will take place.

Transdermal Estradiol Patch

Treatment will be a weekly transdermal patch (0.075 mg) administered in a double-blinded manner. This estradiol dose increases serum estradiol to \~90 pg/mL. Compliance to the intervention will be monitored by having participants keep a log that tracks patch use.

Transdermal Placebo Patch

Treatment will be a weekly transdermal patch (placebo inactive) administered in a double-blinded manner. Compliance to the intervention will be monitored by having participants keep a log that tracks patch use.

Primary outcome measure

  • Brachial artery flow mediated dilation (FMD) [ Time Frame: Baseline and at 2 and 20 weeks ]

Central Contacts and Locations

Central contacts

Kerrie Moreau, PhD

303-724-1914kerrie.moreau@cuanschutz.edu

Claire Cox, BA

303-724-1396claire.cox@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kerrie L Moreau, PhD

303-724-1914kerrie.moreau@ucdenver.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 20, 2024

Last verified

Jun, 2024

Keywords

  • Vascular biology
  • Women's health
  • Women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-06-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.