Conditions: Menopause
Keywords: vaginal atrophy vaginal dryness vaginal itching vaginal pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 622
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: DR-2041a intervention 2: DR-2041b intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 2: 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 3: 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 4: 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Protocol document: