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Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Atrophic Vaginitis
Atrophy
Vaginitis

Treatments

Drug: PVC (twice weekly)
Drug: PVC (daily for 21 days, 7 days off)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00137371
0713S5-413

Details and patient eligibility

About

This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.

Sex

Female

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse.

The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.

Exclusion criteria

Women who do not have a clinical diagnosis of atrophic vaginitis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

49

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Data sourced from clinicaltrials.gov

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