NCT00464971 is a Phase 3 clinical trial of estradiol, 25 mcg in Menopause, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT00464971?

NCT00464971 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT00464971?

Interventions in NCT00464971: estradiol, 25 mcg.

What condition does NCT00464971 study?

NCT00464971 studies Menopause, Postmenopausal Vaginal Atrophy.

Is NCT00464971 still recruiting?

NCT00464971 is currently completed. Last updated 1 March 2017.

Last reviewed 2017-03-01 · How we verify

NCT00464971

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

Completed Phase 3 Last updated 1 March 2017

What this trial tests

Phase 3 trial testing estradiol, 25 mcg in Menopause in 102 participants. Completed in 30 November 1996.

Timeline

31 January 1995

Primary endpoint
30 November 1996

30 November 1996

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	31 January 1995
Primary completion	30 November 1996
Estimated completion	30 November 1996

Drugs / interventions tested

estradiol, 25 mcg — full drug profile →

Conditions studied

Menopause — all drugs for Menopause →
Postmenopausal Vaginal Atrophy — all drugs for Postmenopausal Vaginal Atrophy →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 45 to 80, female only, with Menopause or Postmenopausal Vaginal Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial.
Bachmann G, Lobo RA, Gut R, Nachtigall L, et al · · 2008 · cited 114× · PMID 18165394 · DOI 10.1097/01.aog.0000296714.12226.0f

Verify or expand the search:

Other trials of estradiol, 25 mcg

Trials testing the same drug.

NCT00560924 — Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal W · Phase 3 · terminated
NCT00465192 — Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis · Phase 3 · completed

Other recruiting trials for Menopause

Currently open trials in the same condition.

NCT07472881 — Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women · NA · recruiting
NCT07135232 — The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health. · NA · recruiting
NCT06975111 — Focusing on the Menopausal Transition to Improve Mid-Life Women's Health · Phase 2, PHASE3 · recruiting
NCT07393672 — Effects of Hemp-Derived Cannabinoids on Menopause Symptoms · Phase 2 · recruiting
NCT07412093 — The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxie · NA · active not recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00464971 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 1 March 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00464971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing