CClinicalTrials.gg
Sign In
CompletedNCT00464971Updated Mar 1, 2017

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

A Phase 3 interventional study of estradiol, 25 mcg in Menopause and Postmenopausal Vaginal Atrophy, sponsored by Novo Nordisk A/S. Completed. Open to female participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 12 years 2 months after the study started (first participant enrolled Jan 1995, registered Apr 2007).
Phase
Phase 3
Study type
Interventional
Enrollment
102
Allocation
Non-randomized
Ages
45 Years to 80 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Menopause
  • Postmenopausal Vaginal Atrophy
03

In context

Vaginitis

115 studies on the registry are indexed under Vaginitis; 16 are open to participants now.

This study's planned enrollment of 102 is close to the median of 100 across 90 interventional studies indexed under Vaginitis.

Browse Vaginitis studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Generally healthy
  • Postmenopausal
  • Hysterectomized or non-hysterectomized
  • Moderate or severe vaginal dryness and soreness
  • Successful completion of the study VAG/PD/009/USA

Exclusion criteria

Exclusion Criteria:

  • Known, suspected, or past history of breast cancer
  • Known, suspected, or past history of hormone-dependent tumor
  • Genital bleeding of unknown etiology
  • Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
  • Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
  • Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (estimated)

Interventions

  • Drugestradiol, 25 mcg
06

What researchers measure

Primary outcomes

  1. Relief of vaginal symptoms

    Time frame: over 12 months of treatment

  2. Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels

Secondary outcomes

  1. Vaginal health, vaginal cytology and urethral cytology

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):67-76. doi: 10.1097/01.AOG.0000296714.12226.0f. PubMed 18165394 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00464971
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 24, 2007
Start date
Jan 31, 1995
Primary completion
Nov 30, 1996
Completion
Nov 30, 1996
Last update
Mar 1, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vaginitis→

Other studies from this sponsor

Novo Nordisk A/S

Start the discussion