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A Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%) to Estrace® Cream (0.01%) in Postmenopausal Females With Atrophic Vaginitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02995694
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Information provided by (Responsible Party):
Alvogen Pine Brook LLC

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.

Condition or disease Intervention/treatment Phase
Atrophic Vaginitis Drug: Estradiol Drug: Placebos Drug: Reference Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 533 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
Study Start Date : April 2016
Actual Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
Experimental: Test
Estradiol Vaginal Cream
Drug: Estradiol
Estradiol Vaginal Cream
Other Name: Estadiol Vaginal Cream

Active Comparator: Reference.
Estrace Vaginal Cream
Drug: Reference
Estrace Vaginal Cream
Other Name: Topical Vaginal Cream

Placebo Comparator: Placebos
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Drug: Placebos
Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Other Name: Topical Vaginal Cream

Primary Outcome Measures :
  1. Vaginal Cytology [ Time Frame: Day 8 ]
    Proportion of patients in PP population identified as responders at end of the study.

Secondary Outcome Measures :
  1. Patient self-assessment of the symptoms of vulvar and vaginal atrophy [ Time Frame: Day 8 ]
    Evaluation and comparison between treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed Informed Consent that meets all criteria of current FDA regulations
  2. Females age: 30-75 years old inclusive who are postmenopausal.
  3. 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.
  4. 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.
  5. Normal breast exam at screening and mammogram completed within 9 months prior to screening in patients >40 years old.
  6. For women with an intact uterus, an endometrial thickness < 4 mm as determined by vaginal ultrasonography.
  7. Documented PAP smear conducted within previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol

Exclusion Criteria:

  1. Females younger than 30 years of age or older than 75 years of age
  2. Patients with a serum FSH level of ≤ 40mIU/ml at screening.
  3. Greater than 5% superficial cells on vaginal cytology.
  4. Vaginal pH ≤ 5
  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.
  6. 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.
  7. 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.
  8. Patients with baseline systolic blood pressure of > 150mm Hg and/or diastolic pressure > 90 mm Hg
  9. Any patient with undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.
  10. Any history of estrogen-dependent neoplasia (e.g., endometrial cancer).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02995694

Sponsors and Collaborators
Alvogen Pine Brook LLC
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Study Chair: Meena Venugopal, Ph.D. Alvogen Pine Brook LLC

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Responsible Party: Alvogen Pine Brook LLC Identifier: NCT02995694     History of Changes
Other Study ID Numbers: 71462901
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Atrophic Vaginitis
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female