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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic Conjugated estrogens, B | Drug | 1 (0.3mg) tablet daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the symptom identified by the patient to be most bothersome | Randomization to Week 12 | |
| Mean change in vaginal pH | Randomization to Week 12 | |
| Mean change in maturation index | Randomization to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of Enjuvia | Duration of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duraemd Protocol Chair | Duramed Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Duramed Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18053998 | Derived | 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. doi: 10.1016/j.fertnstert.2007.07.1359. Epub 2007 Dec 3. |
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| Placebo | Other | 1 tablet daily |
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| Duramed Investigational Site | Carmichael | California | 95608 | United States |
| Duramed Investigational Site | San Diego | California | 92103 | United States |
| Duramed Investigational Site | San Diego | California | 92108 | United States |
| Duramed Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| Duramed Investigational Site | Denver | Colorado | 80202 | United States |
| Duramed Investigational Site | Gainesville | Florida | 32607 | United States |
| Duramed Investigational Site | Miami | Florida | 33143 | United States |
| Duramed Investigational Site | Miami | Florida | 33186 | United States |
| Duramed Investigational Site | Sarasota | Florida | 34239 | United States |
| Duramed Investigational Site | Venice | Florida | 34285 | United States |
| Duramed Investigational Site | Alpharetta | Georgia | 30005 | United States |
| Duramed Investigational Site | Boise | Idaho | 83712 | United States |
| Duramed Investigational Site | Evansville | Indiana | 47714 | United States |
| Duramed Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Duramed Investigational Site | Laurel | Maryland | 20707 | United States |
| Duramed Investigational Site | Billings | Montana | 59101 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Duramed Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Duramed Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Duramed Investigational Site | Cleveland | Ohio | 44122 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43213 | United States |
| Duramed Investigational Site | Mayfield Heights | Ohio | 44124 | United States |
| Duramed Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Duramed Investigational Site | Medford | Oregon | 97504 | United States |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Duramed Investigational Site | Columbia | South Carolina | 29201 | United States |
| Duramed Investigational Site | Clarksville | Tennessee | 37043 | United States |
| Duramed Investigational Site | Memphis | Tennessee | 38120 | United States |
| Duramed Investigational Site | Fort Worth | Texas | 76104 | United States |
| Duramed Investigational Site | San Antonio | Texas | 78229 | United States |
| Duramed Investigational Site | Sugarland | Texas | 77478 | United States |
| Duramed Investigational Site | Newport News | Virginia | 23602 | United States |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | United States |
| Duramed Investigational Site | Spokane | Washington | 99207 | United States |
| Duramed Investigational Site | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C509657 | estrogens, conjugated synthetic B |
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