Trials / Completed
CompletedNCT05645406
Estrogen Hormone Products
Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- Female
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose is to determine if the two estradiol products can deliver similar amounts of estradiol after single and multiple dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Divigel 0.1% Topical Gel | estradiol topical products |
| DRUG | Compounded estradiol product | estradiol topical products |
Timeline
- Start date
- 2024-05-14
- Primary completion
- 2025-06-12
- Completion
- 2025-06-15
- First posted
- 2022-12-09
- Last updated
- 2025-11-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05645406. Inclusion in this directory is not an endorsement.