Phase 3
N=622
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Menopause
Bottom Line
View on ClinicalTrials.gov: NCT00361569 ↗Enrolled (actual)
622
Serious AEs
1.0%
Results posted
Apr 2009
Primary outcome: Primary: Mean Change in the Symptom Identified by the Patient to be Most Bothersome — -1.71; -1.77; -1.11; -1.10 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DR-2041a (Drug); DR-2041b (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Duramed Research
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Symptom Identified by the Patient to be Most Bothersome |
-1.71; -1.77; -1.11; -1.10 | — |
| PRIMARY Mean Change in Vaginal pH |
-1.48; -1.44; -0.31; -0.38 | — |
| PRIMARY Mean Change in Maturation Index |
31.46; 33.27; 5.16; 8.91 | — |
| SECONDARY Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A) |
83; 87; 72; 77 | — |
Summary
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
Eligibility Criteria
Inclusion Criteria
- Naturally or surgically menopausal
- Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Exclusion Criteria
- Known sensitivity or contraindication to estrogens or progestins
- History or current diagnosis endometrial hyperplasia
- Recent history of vaginal bleeding of unknown cause
- Recent history or diagnosis of endometriosis
- Any contraindication to estrogen therapy
Data sourced from ClinicalTrials.gov (NCT00361569). 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.