| September 13, 2005 |
| July 23, 2009 |
| November 2004 |
| February 2006 (final data collection date for primary outcome measure) |
- Mean change in the symptom identified by the patient to be most bothersome [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
- Mean change in vaginal pH [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
- Mean change in maturation index [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
|
- Mean change in the symptom identified by the patient to be most bothersome
- Mean change in vaginal pH
- Mean change in maturation index
|
| Complete list of historical versions of study NCT00196378 on ClinicalTrials.gov Archive Site |
| Safety and tolerability of Enjuvia [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy |
| A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women |
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy. |
The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Menopause |
- Drug: Synthetic Conjugated estrogens, B
- Other: Placebo
|
| |
| Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. Epub 2007 Dec 3. |
| |
| Completed |
| 300 |
| February 2006 |
| February 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Naturally or surgically postmenopausal
- 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 of endometrial hyperplasia
- Recent history of vaginal bleeding of unknown cause
- Recent history or diagnosis of endometriosis
- Any contraindication to estrogen therapy
|
| Female |
| 30 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00196378 |
| Duramed Protocol Chair, Duramed Research, Inc. |
| DR-ENJ-301 |
| Duramed Research |
|
| Study Chair: |
Duraemd Protocol Chair |
Duramed Research, Inc. |
|
|
| Duramed Research |
| July 2009 |
