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

G

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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