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

P

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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