Clinical trial
A Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety Following a Single Application of Three Different Doses 0.5 gm (0.5 mg Estradiol), 0.75 gm (0.75 mg Estradiol) and 1.25 gm (1.25 mg Estradiol), a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGelTM 1.25 gm (1 Unit/0.75 mg of Estradiol) to Healthy Post-menopausal Women.
NCT03556800 is registered in ClinicalTrials.gov with Viramal Limited as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety Following a Single Application of Three Different Doses 0.5 gm (0.5 mg Estradiol), 0.75 gm (0.75 mg Estradiol) and 1.25 gm (1.25 mg Estradiol), a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGelTM 1.25 gm (1 Unit/0.75 mg of Estradiol) to Healthy Post-menopausal Women.
- Lead sponsor
- Viramal Limited
- Phase
- Phase 1
- Overall status
- Unknown status
- Start date
- May 22, 2018
- Completion date
- June 30, 2022
- Enrollment
- 20 (estimated)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
menopause