A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

NCT02995694 | Completed Phase 3 Results

• 1 other identifier: 71462901
• Study Type: interventional
• Target: 535
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

Conditions

Atrophic Vaginitis

Outcome Measures

Primary Outcomes (1)

• Vaginal Cytology

  Number of patients in PP population identified as responders at end of the study.

  Day 8

Secondary Outcomes (1)

• Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy

  Day 8

Study Arms (3)

Test

EXPERIMENTAL

Estradiol Vaginal Cream

Drug: Estradiol

Reference.

ACTIVE COMPARATOR

Estrace Vaginal Cream

Drug: Reference

Placebos

PLACEBO COMPARATOR

Placebo with no active pharmaceutical ingredients. Topical vaginal cream

Drug: Placebos

Interventions

Estradiol DRUG

Estradiol Vaginal Cream

Also known as: Estadiol Vaginal Cream

Test

Placebos DRUG

Placebo with no active pharmaceutical ingredients. Topical vaginal cream

Also known as: Topical Vaginal Cream

Placebos

Reference DRUG

Estrace Vaginal Cream

Also known as: Topical Vaginal Cream

Reference.

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent that meets all criteria of current FDA regulations
• Females age: 30-75 years old inclusive who are postmenopausal.
• Postmenopausal defined as at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ml or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. Hysterectomy without oophorectomy if of age that investigator believes would have naturally reached 12 months of spontaneous amenorrhea.
• Baseline evaluation requirements:
• ≤5% superficial cells on vaginal smear cytology
• Vaginal pH \> 5.0
• At least one patient self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy (VVA) from the following list that is identified by the subject:
• Vaginal dryness
• Vaginal and/or vulvar irritation/itching
• Dysuria
• Vaginal pain associated with sexual activity\*
• Vaginal bleeding associated with sexual activity (absence vs. presence)\* \*provided that patient is currently sexually active and plans to remain so throughout study.
• Normal breast exam at screening and mammogram completed within 9 months prior to screening in patients \>40 years old.
• For women with an intact uterus, an endometrial thickness \< 4 mm as determined by vaginal ultrasonography.
• Documented PAP smear conducted within previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol

You may not qualify if:

• Females younger than 30 years of age or older than 75 years of age
• Patients with a serum FSH level of ≤ 40mIU/ml at screening.
• Greater than 5% superficial cells on vaginal cytology.
• Vaginal pH ≤ 5
• Significant history or current evidence of chronic infectious disease, system disorder, organ disorder (including significant liver/kidney impairment) or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
• Patients with an intact uterus should have vaginal ultrasonography results to confirm an inactive endometrial lining. Patients with an endometrial thickness equal to or greater than 4mm should be excluded.
• Patients with known, suspected or current history of carcinoma of the breast. All patients over the age of 40 must have had a mammogram performed within 9 months of the study start and all patients will have a physical breast exam performed at screening.
• Patients with baseline systolic blood pressure of \> 150mm Hg and/or diastolic pressure \> 90 mm Hg
• Any patient with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
• Any history of estrogen-dependent neoplasia (e.g., endometrial cancer).

Sponsors & Collaborators

• Alvogen Pine Brook LLC: lead

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Estradiol; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Results Point of Contact

• Title: Meena Venugopal
• Organization: Alvogen Pine Brook

meena.venugopal@alvogen.com

973-532-7824

Study Officials

• Meena Venugopal, Ph.D.

  Alvogen Pine Brook LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 1, 2021
• Results First Posted: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share