Completed PHASE1 INTERVENTIONAL 2-arm NCT01085877

Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

An Open Randomized Two-Way Cross-Over Comparative Bioavailability Study to Compare the Extent of Systemic Absorption of Estradiol After a Single Dose Treatment With Two 25 mcg Estradiol Vaginal Tablet Formulations Administered in Postmenopausal Women With Vaginal Atrophy

Sponsor: Novo Nordisk A/S

Conditions Menopause Postmenopausal Vaginal Atrophy

Interventions estradiol, 25 mcg

Updated 6 times since 2017 Last updated: Jun 25, 2014 Started: Mar 31, 2010 Primary completion: May 31, 2010 Completion: May 31, 2010

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 Postmenopausal Vaginal Atrophy and is currently completed. Novo Nordisk A/S leads this study, which shows 6 recorded versions since 2010 — 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 PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Mar 2010

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

• Mainz, Germany