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NCT06264882: LILAC
Cardiometabolic Consequences of the Loss of Ovarian Function
Phase 4 trial testing Degarelix in Menopause in 100 participants. Currently enrolling.
31 May 2028
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 100 |
| Start date | 1 June 2024 |
| Primary completion | 31 May 2028 |
| Estimated completion | 31 August 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Degarelix (degarelix) — full drug profile →
- Transdermal Estradiol Patch
- Transdermal Placebo Patch
Conditions studied
- Menopause — all drugs for Menopause →
- Estrogen Deficiency — all drugs for Estrogen Deficiency →
- Aging — all drugs for Aging →
- Adiposity — all drugs for Adiposity →
Sponsor
University of Colorado, Denver
Who can join
Adults 20 to 45, female only, with Menopause or Estrogen Deficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06264882
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Menopause
Currently open trials in the same condition.
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- NCT07393672 — Effects of Hemp-Derived Cannabinoids on Menopause Symptoms · Phase 2 · recruiting
- NCT07412093 — The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxie · NA · active not recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06264882 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 20 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06264882.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing