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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
622
Mean Change in the Symptom Identified by the Patient to be Most Bothersome
Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Time frame: Baseline to Week 12
Mean Change in Vaginal pH
Change= Week 12 vaginal pH - Baseline vaginal pH
Time frame: Baseline to Week 12
Mean Change in Maturation Index
Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \* 0) + (% Intermediate Cells \* 0.5) + (% Superficial Cells \* 1.0)
Time frame: Baseline to Week 12
Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)
Any adverse event reported from the beginning of the 28-day screening through the subject's last report.
Time frame: Up to Week 12
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2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Carmichael, California, United States
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Fresno, California, United States
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San Diego, California, United States
...and 87 more locations