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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: February 2, 2007
Last updated: February 6, 2017
Last verified: February 2017
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Condition Intervention Phase
Menopause Postmenopausal Vaginal Atrophy Drug: estradiol, 10 mcg Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies [ Time Frame: Week 52 ]
    The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.

Secondary Outcome Measures:
  • Transvaginal Ultrasound: Endometrial Thickness [ Time Frame: Week 0, week 52 ]
    Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.

Enrollment: 336
Study Start Date: January 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vagifem® 10 mcg
One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
Drug: estradiol, 10 mcg
Tablets, administered intravaginally twice weekly


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Postmenopausal women whose last menstruation was at least two years prior to the time of screening
  • At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
  • Generally healthy

Exclusion Criteria:

  • Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months
  Contacts and Locations
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Please refer to this study by its identifier: NCT00431132

  Show 42 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00431132     History of Changes
Other Study ID Numbers: VAG-1748
2006-001629-24 ( EudraCT Number )
Study First Received: February 2, 2007
Results First Received: February 7, 2011
Last Updated: February 6, 2017

Additional relevant MeSH terms:
Atrophic Vaginitis
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female processed this record on September 20, 2017