A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Menopause

Treatments: Other: Placebo; Drug: DR-2041b; Drug: DR-2041a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00361569

DR-CEN-302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 622 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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622 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: DR-2041a

2

Experimental group

Treatment:

Drug: DR-2041b

3

Placebo Comparator group

Treatment:

Other: Placebo

Other: Placebo

4

Placebo Comparator group

Treatment:

Other: Placebo

Other: Placebo