deltatrials
Unknown PHASE1 INTERVENTIONAL 4-arm NCT03556800

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

Conditions Menopause
Interventions Estrogel
Updated 15 times since 2018 Last updated: Apr 26, 2022 Started: May 22, 2018 Primary completion: Jun 30, 2022 Completion: Jun 30, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Oct 2019 · 7 months · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Mar 2022 · 11 months · monthly snapshot~Mar 2022 – ~May 2022 · 2 months · monthly snapshot~May 2022 – ~May 2024 · 24 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

15 versions recorded
  1. Sep 2024 — Present [monthly]

    Unknown PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE1

    Status: Unknown StatusUnknown

  3. May 2024 — Jul 2024 [monthly]

    Unknown Status PHASE1

    Status: RecruitingUnknown Status

  4. May 2022 — May 2024 [monthly]

    Recruiting PHASE1

  5. Mar 2022 — May 2022 [monthly]

    Recruiting PHASE1

Show 10 earlier versions
  1. Apr 2021 — Mar 2022 [monthly]

    Recruiting PHASE1

  2. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  3. Jun 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  4. Feb 2020 — Jun 2020 [monthly]

    Recruiting PHASE1

  5. Dec 2019 — Feb 2020 [monthly]

    Recruiting PHASE1

  6. Oct 2019 — Dec 2019 [monthly]

    Recruiting PHASE1

  7. Mar 2019 — Oct 2019 [monthly]

    Recruiting PHASE1

  8. Dec 2018 — Mar 2019 [monthly]

    Recruiting PHASE1

  9. Sep 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  10. 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

Sponsor contact:
  • Simbec Research
  • Viramal Limited
Data source: Viramal Limited

For direct contact, visit the study record on ClinicalTrials.gov .