deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT00431132

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

Sponsor: Novo Nordisk A/S

Interventions estradiol, 10 mcg
Updated 12 times since 2017 Last updated: Feb 6, 2017 Started: Jan 31, 2007 Primary completion: Nov 30, 2008 Completion: Nov 30, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00431132, this PHASE3 trial focuses on Menopause and Postmenopausal Vaginal Atrophy and remains completed. Sponsored by Novo Nordisk A/S, it has been updated 12 times since 2007, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~May 2017 · 3 months · monthly snapshotCompleted~May 2017 – ~Jun 2018 · 13 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

Show 7 earlier versions
  1. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

  2. Dec 2021 — Dec 2022 [monthly]

    Completed PHASE3

  3. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  5. May 2017 — Jun 2018 [monthly]

    Completed PHASE3

  6. Feb 2017 — May 2017 [monthly]

    Completed PHASE3

  7. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Jan 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novo Nordisk A/S
Data source: Novo Nordisk A/S

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