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PVC

Phase 3

Atrophic Vaginitis | Small molecule | Endocrine |Pfizer, Inc.|Last 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

Clinical trial landscape

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 an investigational small molecule being developed for the treatment of atrophic vaginitis, a condition characterized by thinning and inflammation of the vaginal walls due to decreased estrogen levels. It is being studied in postmenopausal women aged 45 years and older.

Who makes PVC?

PVC is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is PVC in?

PVC is currently in Phase 3 clinical development. It has completed one Phase 3 trial, which involved 480 participants. As an investigational drug, it has not yet been approved by regulatory authorities and remains under evaluation for its intended use.

What clinical trials is PVC in?

PVC has been studied in one completed Phase 3 clinical trial with the identifier NCT00137371. This trial evaluated conjugated estrogen cream for atrophic vaginitis and enrolled 480 female participants in the United States and Canada. The study was randomized and double-blind.

Is PVC the same as conjugated estrogen cream?

PVC is the drug being evaluated in a clinical trial titled 'Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis.' The trial uses a conjugated estrogen cream formulation, which is the active treatment being tested for its effects on atrophic vaginitis symptoms.