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PVC

Phase 3

Atrophic Vaginitis | Small molecule | Endocrine |Pfizer, Inc.|Trials Updated: Dec 10, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment480

FDA Designations

No designations recorded

PVC clinical trials

PVC · 1 trial · 3 indications

Phase 3 1
NCT00137371Study Evaluating Conjugated Estrogen Cream for Atrophic VaginitisAtrophic Vaginitis
COMPLETED480 Analytics
PHASE3COMPLETED
Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
Atrophic VaginitisUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.

Secondary Endpoints

To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
PVC (daily for 21 days, 7 days off)DRUG -
PVC (twice weekly)DRUG -
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Eligibility Criteria

Age Range45 Years to 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites49

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...

Countries:United StatesCanada
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Frequently asked questions about PVC

What is PVC used for?

PVC is being studied for the treatment of atrophic vaginitis, a condition involving atrophy and inflammation of the vaginal tissue. It is a small molecule developed by Pfizer, Inc. in the endocrine therapeutic area. The clinical program has focused on women aged 45 years and older.

Who makes PVC?

PVC is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 3 clinical trial evaluating the therapy in atrophic vaginitis. The program includes one completed study conducted in the United States and Canada.

What phase is PVC in?

PVC is in Phase 3 clinical development for atrophic vaginitis. One Phase 3 trial has been completed, and no trials are currently active. The completed study enrolled 480 participants and was randomized and double blind.

What clinical trials is PVC in?

PVC has been evaluated in the Phase 3 trial NCT00137371, titled Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis. The trial enrolled 480 female participants aged 45 years and older, was randomized and double blind, and was conducted in the United States and Canada. It is now completed.

Is PVC the same as PVC (daily for 21 days, 7 days off)?

Yes, PVC (daily for 21 days, 7 days off) refers to the same asset as PVC. The parenthetical describes the dosing schedule used for this Pfizer-developed small molecule in its atrophic vaginitis program. Readers searching either name are looking at the same investigational therapy.