Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
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ClinicalTrials.gov Identifier: NCT00431132 |
Recruitment Status
:
Completed
First Posted
: February 5, 2007
Results First Posted
: April 7, 2011
Last Update Posted
: March 15, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menopause Postmenopausal Vaginal Atrophy | Drug: estradiol, 10 mcg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 336 participants |
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 |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
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
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Drug: estradiol, 10 mcg
Tablets, administered intravaginally twice weekly
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- 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.
- 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.

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431132

Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00431132 History of Changes |
Other Study ID Numbers: |
VAG-1748 2006-001629-24 ( EudraCT Number ) |
First Posted: | February 5, 2007 Key Record Dates |
Results First Posted: | April 7, 2011 |
Last Update Posted: | March 15, 2017 |
Last Verified: | February 2017 |
Additional relevant MeSH terms:
Atrophy Vaginitis Atrophic Vaginitis Pathological Conditions, Anatomical Vaginal Diseases Genital Diseases, Female Estradiol Polyestradiol phosphate Estradiol 3-benzoate |
Estradiol 17 beta-cypionate Estradiol valerate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female |