FindTrial
Sign In

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

A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02668796
Enrollment
522
Registered
2016-01-29
Start date
2016-01-31
Completion date
2016-09-21
Last updated
2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar and Vaginal Atrophy

Brief summary

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.

Interventions

DRUGEstradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

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

apply using the given applicator

DRUGPlacebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)

apply using the given applicator

Sponsors

Glenmark Pharmaceuticals Ltd. India
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The proportion of subjects with at least 25% reduction from baseline in the sum of % basal/parabasal + %intermediate cells on vaginal cytology and vaginal pH <5.0 with a change from baseline vaginal pH of at least 0.5Day 15]

Secondary

MeasureTime frame
The proportion of subjects with treatment success at the end of study where treatment success is defined as a subject who achieves a score of 0 (none) or 1 (mild) at Visit 3/End of Study for the MBSDay 15]

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026