Phase 3
N=336
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Menopause · Postmenopausal Vaginal Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT00431132 ↗Enrolled (actual)
336
Serious AEs
4.2%
Results posted
Apr 2011
Primary outcome: Primary: Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies — 0; 0; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- estradiol, 10 mcg (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies |
0; 0; 0; 0; 0 | — |
| SECONDARY Transvaginal Ultrasound: Endometrial Thickness |
2.04; 1.94 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00431132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.