Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGel 1.25 gm to Healthy Post-menopausal Women.
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.
Sponsor: Simbec Research
This PHASE1 trial investigates Menopause and is currently ongoing. Simbec Research leads this study, which shows 15 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
15 versions recorded-
Sep 2024 — Present [monthly]
Unknown PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE1
Status: Unknown Status → Unknown
-
May 2024 — Jul 2024 [monthly]
Unknown Status PHASE1
Status: Recruiting → Unknown Status
-
May 2022 — May 2024 [monthly]
Recruiting PHASE1
-
Mar 2022 — May 2022 [monthly]
Recruiting PHASE1
▶ Show 10 earlier versions
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Apr 2021 — Mar 2022 [monthly]
Recruiting PHASE1
-
Jan 2021 — Apr 2021 [monthly]
Recruiting PHASE1
-
Jun 2020 — Jan 2021 [monthly]
Recruiting PHASE1
-
Feb 2020 — Jun 2020 [monthly]
Recruiting PHASE1
-
Dec 2019 — Feb 2020 [monthly]
Recruiting PHASE1
-
Oct 2019 — Dec 2019 [monthly]
Recruiting PHASE1
-
Mar 2019 — Oct 2019 [monthly]
Recruiting PHASE1
-
Dec 2018 — Mar 2019 [monthly]
Recruiting PHASE1
-
Sep 2018 — Dec 2018 [monthly]
Recruiting PHASE1
-
Jul 2018 — Sep 2018 [monthly]
Recruiting PHASE1
First recorded
May 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Simbec Research
- Viramal Limited
For direct contact, visit the study record on ClinicalTrials.gov .