Vaginitis AtropicPhase 4NCT03032848
Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients
A Phase 4 study testing Conjugated Estrogen, Promestriene and Estriol in people with Vaginitis Atropic and Pelvic Organ Prolapse, run by Universidade Federal do Paraná.
Trial summary
To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginitis Atropic, Pelvic Organ Prolapse, Endometrial Hyperplasia
- What is being tested?
- Conjugated Estrogen, Promestriene and Estriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2013to 26 Dec 2016
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- post menopause women
- normal oncotic cytology and mammogram
- any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm
Who cannot join
- vaginal bleeding
- hormonal replacement on the past three months
- renal or hepatic desease
- porfiria
- past venous thromboembolism; ulcerated prolapse
About this study
Official title: Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.
- Being tested
- Conjugated Estrogen, Promestriene, Estriol, Vaginal Moisturizer - Cream
- Medical subject headings
- Atrophic Vaginitis, Pelvic Organ Prolapse, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugated EstrogenDrug
Also called Premarin
use of 1 gram per day
PromestrieneDrug
Also called Colpotrofine
use of 1 gram per day
EstriolDrug
Also called Stelle
use of 1 gram per day
Vaginal Moisturizer - CreamDrug
Also called Vagidrat
use of 1 gram per day
| Study group | Role | What they receive |
|---|---|---|
| Conjugated Estrogen Group | Active comparator | use of 1 gram per day Receives: Drug: Promestriene; Drug: Estriol; Drug: Vaginal Moisturizer - Cream |
| Promestriene Group | Active comparator | use of 1 gram per day Receives: Drug: Conjugated Estrogen; Drug: Estriol; Drug: Vaginal Moisturizer - Cream |
| Estriol Group | Active comparator | use of 1 gram per day Receives: Drug: Conjugated Estrogen; Drug: Promestriene; Drug: Vaginal Moisturizer - Cream |
| Vaginal Moisturizer Cream | Placebo comparator | use of 1 gram per day Receives: Drug: Conjugated Estrogen; Drug: Promestriene; Drug: Estriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the histopathological effects on endometrium after each treatment
Compare the histopathological results after treatment on each group and among each other
Measured: 48 days
Compare the endometrial thickness measured by ultrassound after each treatment
Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other
Measured: 48 days
Secondary outcomes (2)
Evaluate the changes of maturation index (Meisels Index) after each treatement
Compare the changes on Meisels Index after each treatment and among each other
Measured: 48 days
Evaluate the changes on climacteric complaints after each treatment
Compare the changes on systemic and genital complaints after each treatment, and among each other
Measured: 48 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start26 Nov 2013
- Primary completion20 Dec 2016
- Study completion26 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaginitis AtropicStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Chicareli Pinhat, Universidade Federal do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032848
- Sponsor's protocol ID
- 23286013.7.0000.0096
- Other IDs
- 475.622
- Status last verified
- Apr 2019
- First submitted
- 20 Jan 2017
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
PubMed 23985562Taithongchai 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 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
- ClinicalTrials.gov ID
- NCT03032848
- Acronym / sponsor ID
- 23286013.7.0000.0096
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Study start
- 26 Nov 2013 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 26 Dec 2016 (actual)
- First posted
- 26 Jan 2017 (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.
To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conjugated Estrogen Group | Active comparator | Drug: Promestriene, Drug: Estriol, Drug: Vaginal Moisturizer - Creamuse of 1 gram per day |
| Promestriene Group | Active comparator | Drug: Conjugated Estrogen, Drug: Estriol, Drug: Vaginal Moisturizer - Creamuse of 1 gram per day |
| Estriol Group | Active comparator | Drug: Conjugated Estrogen, Drug: Promestriene, Drug: Vaginal Moisturizer - Creamuse of 1 gram per day |
| Vaginal Moisturizer Cream | Placebo comparator | Drug: Conjugated Estrogen, Drug: Promestriene, Drug: Estrioluse of 1 gram per day |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- post menopause women
- normal oncotic cytology and mammogram
- any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm
Key exclusion criteria (5 listed)
- vaginal bleeding
- hormonal replacement on the past three months
- renal or hepatic desease
- porfiria
- past venous thromboembolism; ulcerated prolapse
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 |
|---|---|---|
| Conjugated EstrogenAlso: Premarinuse of 1 gram per day | Drug | Estriol Group, Promestriene Group, Vaginal Moisturizer Cream |
| PromestrieneAlso: Colpotrofineuse of 1 gram per day | Drug | Conjugated Estrogen Group, Estriol Group, Vaginal Moisturizer Cream |
| EstriolAlso: Stelleuse of 1 gram per day | Drug | Conjugated Estrogen Group, Promestriene Group, Vaginal Moisturizer Cream |
| Vaginal Moisturizer - CreamAlso: Vagidratuse of 1 gram per day | Drug | Conjugated Estrogen Group, Estriol Group, Promestriene Group |
Primary outcome
Evaluate the histopathological effects on endometrium after each treatment
Time frame: 48 days
Compare the histopathological results after treatment on each group and among each other
Compare the endometrial thickness measured by ultrassound after each treatment
Time frame: 48 days
Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other
2 secondary outcomes
Evaluate the changes of maturation index (Meisels Index) after each treatement
Time frame: 48 days
Evaluate the changes on climacteric complaints after each treatment
Time frame: 48 days
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 1 May 2019.
- Results publication: PubMed 23985562Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
- 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.
- Individual participant dataSharing planned: Yes
Related trials for Vaginitis Atropic
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conjugated Estrogen, Promestriene and Estriol in people with Vaginitis Atropic and Pelvic Organ Prolapse, run by Universidade Federal do Paraná.
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 3 inclusion and 5 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate the histopathological effects on endometrium after each treatment (time frame: 48 days). The study lists 2 primary outcomes in all. 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 NCT03032848, which also lists 2 linked publications.
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 1 May 2019.