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Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Tucson, Arizona, 85715 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrophic Vaginitis, Atrophy, Vaginitis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00137371
Pfizer
Completed
Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

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Descriptive Information
Brief Title  ICMJE Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
Official Title  ICMJE Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Atrophic Vaginitis
  • Atrophy
  • Vaginitis
Intervention  ICMJE
  • Drug: PVC (daily for 21 days, 7 days off)
  • Drug: PVC (twice weekly)
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 25, 2005)
480
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137371
Other Study ID Numbers  ICMJE 0713S5-413
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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