Pelvic Organ ProlapsePhase 3NCT00803335
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
A Phase 3 study testing Vaginal conjugated estrogen cream 0.5gm and Vaginal conjugated estrogen cream 1.0gm in people with Pelvic Organ Prolapse and Vaginal Atrophy, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Vaginal Atrophy
- What is being tested?
- Vaginal conjugated estrogen cream 0.5gm and Vaginal conjugated estrogen cream 1.0gm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to May 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 45 years or older
- Postmenopausal (>55 if natural menopause)
- Clinical atrophic vaginitis (at least mild atrophy)
- Pelvic organ prolapse(at least stage 2 or greater)
- Posthysterectomy
- Surgery date between 2-12 weeks after recruitment
Who cannot join
- Uterus present
- Well-estrogenized appearing vagina
- Known or suspected history of breast carcinoma
- Hormone-dependent tumor
- Genital bleeding of unknown cause
- Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
Show all 11Show fewer
- Vaginal infection requiring treatment
- Allergy to estrogen or its constituents
- Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
- Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
- Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)
Trial locations and contacts
1 site in 1 country.
United States1 site
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
Cincinnati, Ohio, 45220
About this study
Official title: The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial
The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.
Read the detailed description
Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.
- Conditions
- Pelvic Organ Prolapse, Vaginal Atrophy
- Being tested
- Vaginal conjugated estrogen cream 0.5gm, Vaginal conjugated estrogen cream 1.0gm
- Keywords
- pelvic organ prolapse, vaginal atrophy, atrophic vaginitis, postmenopausal, posthysterectomy, vaginal health, vaginal cytology, vaginal maturity index, vaginal histology, quality of life questionnaires
- Medical subject headings
- Pelvic Organ Prolapse, Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal conjugated estrogen cream 0.5gmDrug
Also called Premarin
Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.
Vaginal conjugated estrogen cream 1.0gmDrug
Also called Premarin
Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.
| Study group | Role | What they receive |
|---|---|---|
| Premarin cream 0.5gm | Active comparator | Application of 0.5gm of vaginal estrogen cream nightly until surgery. Receives: Drug: Vaginal conjugated estrogen cream 0.5gm |
| Premarin cream 1.0gm | Active comparator | Application of 1.0gm of vaginal estrogen cream nightly until surgery. Receives: Drug: Vaginal conjugated estrogen cream 1.0gm |
| No intervention | No intervention | Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.
Measured: baseline and 2-12 weeks after treatment (at time of surgery)
Secondary outcomes (1)
Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.
Measured: baseline and 2-12 weeks after treatment (at time of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine M Vaccaro, DO, Principal investigator, Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803335
- Sponsor's protocol ID
- 08135-08-076
- Status last verified
- Feb 2014
- First submitted
- 4 Dec 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
PubMed 37431855
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00803335
- Acronym / sponsor ID
- 08135-08-076
- Conditions
- Pelvic Organ Prolapse, Vaginal Atrophy
- Keywords
- pelvic organ prolapse, vaginal atrophy, atrophic vaginitis, postmenopausal, posthysterectomy, vaginal health, vaginal cytology, vaginal maturity index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Dec 2008 (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.
The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.
Detailed description
Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Premarin cream 0.5gm | Active comparator | Drug: Vaginal conjugated estrogen cream 0.5gmApplication of 0.5gm of vaginal estrogen cream nightly until surgery. |
| Premarin cream 1.0gm | Active comparator | Drug: Vaginal conjugated estrogen cream 1.0gmApplication of 1.0gm of vaginal estrogen cream nightly until surgery. |
| No intervention | No intervention | –Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 45 years or older
- Postmenopausal (>55 if natural menopause)
- Clinical atrophic vaginitis (at least mild atrophy)
- Pelvic organ prolapse(at least stage 2 or greater)
- Posthysterectomy
Key exclusion criteria (11 listed)
- Uterus present
- Well-estrogenized appearing vagina
- Known or suspected history of breast carcinoma
- Hormone-dependent tumor
- Genital bleeding of unknown cause
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 |
|---|---|---|
| Vaginal conjugated estrogen cream 0.5gmAlso: PremarinWomen in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery. | Drug | Premarin cream 0.5gm |
| Vaginal conjugated estrogen cream 1.0gmAlso: PremarinWomen in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery. | Drug | Premarin cream 1.0gm |
Primary outcome
Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.
Time frame: baseline and 2-12 weeks after treatment (at time of surgery)
1 secondary outcome
Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.
Time frame: baseline and 2-12 weeks after treatment (at time of surgery)
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 27 May 2015.
- Derived from this study: PubMed 37431855Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
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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.
Christine M Vaccaro, DO principal investigator
Good Samaritan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaginal conjugated estrogen cream 0.5gm and Vaginal conjugated estrogen cream 1.0gm in people with Pelvic Organ Prolapse and Vaginal Atrophy, run by TriHealth Inc. at 1 site in United States.
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 6 inclusion and 11 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. (time frame: baseline and 2-12 weeks after treatment (at time of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803335, which also lists 1 linked publication.
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 27 May 2015.