Atrophic VaginitisPhase 3NCT00137371
Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
A Phase 3 study testing PVC (daily for 21 days, 7 days off) and PVC (twice weekly) in people with Atrophic Vaginitis and Atrophy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 49 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Atrophic Vaginitis, Atrophy, Vaginitis
- What is being tested?
- PVC (daily for 21 days, 7 days off) and PVC (twice weekly)
- How many people
- 480 participants
- Where
- 49 sitesin 2 countries
- Study dates
- Aug 2005to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women who do not have a clinical diagnosis of atrophic vaginitis.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States32 sites
Study site
Atlanta, Georgia, 30328
Study site
Augusta, Georgia, 30901
Study site
Aurora, Colorado, 80010
Study site
Brooksville, Florida, 34613
Study site
Carrollton, Texas, 75006
Study site
Carrollton, Texas, 75010
Study site
Chapel Hill, North Carolina, 27514
Study site
Charlottesville, Virginia, 22903
Study site
Chicago, Illinois, 60612
Study site
Colleyville, Texas, 76034
Study site
Dallas, Texas, 75246
Study site
Danville, Pennsylvania, 17822-2920
Study site
Encinitas, California, 92024
Study site
Houston, Texas, 77030
Study site
Metairie, Louisiana, 70006
Study site
Miami, Florida, 33186
Study site
New Brunswick, New Jersey, 08901
Study site
Norfolk, Virginia, 23502
Study site
Oklahoma City, Oklahoma, 73112
Study site
Omaha, Nebraska, 68134
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Plano, Texas, 75093
Study site
San Diego, California, 92108
Study site
St Louis, Missouri, 63141
Study site
St. Petersburg, Florida, 33709
Study site
Tampa, Florida, 33066
Study site
Torrance, California, 90502
Study site
Troy, Michigan, 48084
Study site
Tucson, Arizona, 85715
Study site
West Palm Beach, Florida, 33407
Study site
Winston-Salem, North Carolina, 27103
Canada17 sites
Study site
Calgary, Alberta, T2N 4L7
Study site
Coquitlam, British Columbia, V3K 3V9
Study site
Kingston, Ontario, K7L 2V7
Study site
Langley, British Columbia, V3H 4H9
Study site
Montréal, Quebec, H1T 1P6
Study site
Montréal, Quebec, H2X 1N8
Study site
Montreal, Quebec, H3M 3A9
Study site
Ottawa, Ontario, K1H 7W9
Study site
Pointe-Claire, Quebec, H9R 4S3
Study site
Québec, Quebec, G1L 3L5
Study site
Shawinigan, Quebec, G9N 2H6
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
Toronto, Ontario, M5C 1R6
Study site
Toronto, Ontario, M5G 1Z5
Study site
Toronto, Ontario, M9W 4L6
Study site
Winnipeg, Manitoba, R3A 1M3
Study site
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis
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.
- Conditions
- Atrophic Vaginitis, Atrophy, Vaginitis
- Being tested
- PVC (daily for 21 days, 7 days off), PVC (twice weekly)
- Keywords
- Postmenopause, Vaginitis
- Medical subject headings
- Atrophic Vaginitis, Atrophy, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVC (daily for 21 days, 7 days off)Drug
PVC (twice weekly)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
Secondary outcomes (1)
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startAug 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Principal investigator, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137371
- Sponsor's protocol ID
- 0713S5-413
- Status last verified
- Dec 2007
- First submitted
- 25 Aug 2005
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT00137371
- Acronym / sponsor ID
- 0713S5-413
- Conditions
- Atrophic Vaginitis, Atrophy, Vaginitis
- Keywords
- Postmenopause, Vaginitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who do not have a clinical diagnosis of atrophic vaginitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVC (daily for 21 days, 7 days off) | Drug | – |
| PVC (twice weekly) | Drug | – |
Primary outcome
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
1 secondary outcome
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
Related trials for Atrophic Vaginitis
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Active, not recruiting
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms
Not yet recruitingPhase 4
Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
Postmenopausal Atrophic Vaginitis, Genitourinary Syndrome of Menopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor principal investigator
Wyeth is now a wholly owned subsidiary of Pfizer
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PVC (daily for 21 days, 7 days off) and PVC (twice weekly) in people with Atrophic Vaginitis and Atrophy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 49 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2007.