Completed PHASE3 INTERVENTIONAL NCT00465192

Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Sponsor: Novo Nordisk A/S

Conditions Menopause Postmenopausal Vaginal Atrophy

Interventions estradiol, 10 mcg estradiol, 25 mcg placebo

Updated 6 times since 2017 Last updated: Feb 28, 2017 Started: Aug 31, 1994 Primary completion: Nov 30, 1995 Completion: Nov 30, 1995

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Menopause and Postmenopausal Vaginal Atrophy and is currently completed. Novo Nordisk A/S leads this study, which shows 6 recorded versions since 1994 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Mar 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Mar 2017 [monthly]

Completed PHASE3

First recorded

Aug 1994

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 .

Study Locations

No location information available.