A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Menopause

Treatments: Drug: Synthetic Conjugated estrogens, B; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196378

DR-ENJ-301

Details and patient eligibility

About

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.

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: 300 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Synthetic Conjugated estrogens, B

2

Placebo Comparator group

Treatment:

Other: Placebo