Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy

Padagis

Status and phase: Completed; Phase 3

Conditions: Atrophy

Treatments: Drug: estrace cream (Perrigo); Drug: Placebo cream; Drug: estrace cream (Reference)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02770365

PRG-NY-15-007

Details and patient eligibility

About

To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.

Enrollment: 695 patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• postmenopausal female and otherwise healthy, 30 - 75 years of age.
• ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
• vaginal pH > 5.0 at Visit 1/Screening
• Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
• For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
• Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

Exclusion criteria

• Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.

• Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.

• Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more

• History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.

• Known or suspected estrogen-dependent neoplasia.

• Has deep vein thrombosis, pulmonary embolism or history of these conditions.

  • Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.

• Known acute or chronic hepatic disease or dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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695 participants in 3 patient groups, including a placebo group

Test Product

Experimental group

Description:

estradiol cream

Treatment:

Drug: estrace cream (Perrigo)

Reference Product

Active Comparator group

Description:

estradiol cream

Treatment:

Drug: estrace cream (Reference)

Placebo product

Placebo Comparator group

Description:

Placebo cream

Treatment:

Drug: Placebo cream