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NCT05645406
Estrogen Hormone Products
EARLY_PHASE1 trial testing Divigel 0.1% Topical Gel in Menopause in 8 participants. Completed in 15 June 2025.
12 June 2025
Quick facts
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 8 |
| Start date | 14 May 2024 |
| Primary completion | 12 June 2025 |
| Estimated completion | 15 June 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Divigel 0.1% Topical Gel — full drug profile →
- Compounded estradiol product — full drug profile →
Conditions studied
- Menopause — all drugs for Menopause →
Sponsor
University of Maryland, Baltimore
Who can join
Adults 45 to 65, female only, with Menopause. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose is to determine if the two estradiol products can deliver similar amounts of estradiol after single and multiple dosing.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05645406
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Maryland, Baltimore 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 NCT05645406 (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 Maryland, Baltimore
- Last refreshed: 10 November 2025
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/NCT05645406.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing