To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Vulvar and Vaginal Atrophy

Treatments: Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark); Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark); Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02668796

GLK-1502

Details and patient eligibility

About

This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.

Enrollment: 522 patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female postmenopausal subjects aged >30 to <75 years

2. At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her

   • vaginal dryness
   • vaginal and/or vulvar irritation/ itching
   • dysuria
   • vaginal pain associated with sexual activity
   • presence of vaginal bleeding associated with sexual activity

3. Have <5% superficial cells on vaginal smear cytology and vaginal pH >5.0 at Visit 1

4. Systolic blood pressure <150mm Hg and diastolic blood pressure <90mm Hg at Visit 1

Exclusion criteria

1. Known hypersensitivity to Estradiol vaginal tablet
2. Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
3. History of undiagnosed vaginal bleeding.
4. History of significant risk factors for endometrial cancer
5. For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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522 participants in 3 patient groups, including a placebo group

Estradiol Vaginal Tablets 10 mcg (Glenmark)

Experimental group

Description:

apply using the given applicator

Treatment:

Drug: Estradiol Vaginal Tablets 10 mcg (Glenmark)

Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)

Active Comparator group

Description:

apply using the given applicator

Treatment:

Drug: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)

Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

Placebo Comparator group

Description:

apply using the given applicator

Treatment:

Drug: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)