Genital ProlapsePhase 4VSaENCT02906111
Vaginal Estriol Before and Vaginal Surgery for Prolapse
A Phase 4 study testing estriol and vaginal surgery in people with Genital Prolapse, run by Salvatore Caruso.
Trial summary
The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life. Read more about this study
- Who is it for?
- Ages 56 to 63 years, women only
- Conditions the study is for
- Genital Prolapse
- What is being tested?
- estriol and vaginal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2017
- 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 56 to 63 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- genital dryness,
- irritation/burning/itching of vulvas or vagina
- decreased lubrication with sexual activity
- discomfort or pain with sexual activity
- decreased arousal, orgasm, desire
- dysuria.
Who cannot join
- previous surgeries for pelvic organ prolapse
- urinary incontinence
- usage of medication
- chronic medical illness
- body mass index (BMI) ≥ 35 kg/m2
- endometrial thickness equal to or greater than 4 mm
Show all 14Show fewer
- abnormal uterine bleeding
- hormone-dependent malignancies
- history of thromboembolic disease
- liver disease
- usage of HT for less than 3 months
- usage of phytoestrogens within 1 month before the start of the study
- partner affected by sexual disorder
- conflicting with the partner
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders
The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.
Read the detailed description
The aim of this randomized study was to evaluate the efficacy of low concentration of vaginal estriol gel (0.005%, 50 micrograms/1 g vaginal gel) in women with pelvic statics disorders before vaginal surgical treatment (group A), assessing the vaginal dryness, dysuria, vaginal maturation index (VMI), pH and the Vaginal Health Index (VHI). Secondary, to investigate the changes of sexual function and QoL. Women without pre surgical estriol treatment constituted the control group (group B).
- Conditions
- Genital Prolapse
- Being tested
- estriol, vaginal surgery
- Keywords
- Estriol, Prolapse, Quality of life, Vaginal health, Vaginal surgery
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estriolDrug
Study Group, treated with estriol
Control Group, no drug treatment
Both groups will undergo vaginal surgery for prolapse
vaginal surgeryProcedure or surgery
Also called vaginal surgery for prolapse
Control Group
| Study group | Role | What they receive |
|---|---|---|
| Study Group on estriol vaginal gel | Active comparator | Drug: 1 g/daily of vaginal gel containing 50 μg of estriol (0.005%) for 3 weeks and then twice weekly for 9 weeks, for a complete cycle of treatment of 12 weeks Receives: Drug: estriol; Procedure: vaginal surgery |
| Control group, no estriol treatment | Active comparator | Procedure: vaginal surgery Receives: Procedure: vaginal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Health Indexes
Measured: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Secondary outcomes (2)
QoL and sexual function were investigated by the Short Form 36 (SF-36)
Measured: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively
Measured: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
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 Genital 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salvatore Caruso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salvatore Caruso, Policlinico Universitario, Catania
- Investigators
- Antonio Cianci, Prof, Study chair, Policlinico Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906111
- Sponsor's protocol ID
- MenSurgE2
- Acronym
- VSaE
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Caruso S, Cianci S, Amore FF, Ventura B, Bambili E, Spadola S, Cianci A. Quality of life and sexual function of naturally postmenopausal women on an ultralow-concentration estriol vaginal gel. Menopause. 2016 Jan;23(1):47-54. doi: 10.1097/GME.0000000000000485.
PubMed 26079974Taithongchai 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 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders
- ClinicalTrials.gov ID
- NCT02906111
- Acronym / sponsor ID
- VSaE / MenSurgE2
- Conditions
- Genital Prolapse
- Keywords
- Estriol, Prolapse, Quality of life, Vaginal health, Vaginal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Salvatore CarusoUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Sep 2016 (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 determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.
Detailed description
The aim of this randomized study was to evaluate the efficacy of low concentration of vaginal estriol gel (0.005%, 50 micrograms/1 g vaginal gel) in women with pelvic statics disorders before vaginal surgical treatment (group A), assessing the vaginal dryness, dysuria, vaginal maturation index (VMI), pH and the Vaginal Health Index (VHI). Secondary, to investigate the changes of sexual function and QoL. Women without pre surgical estriol treatment constituted the control group (group B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group on estriol vaginal gel | Active comparator | Drug: estriol, Procedure: vaginal surgeryDrug: 1 g/daily of vaginal gel containing 50 μg of estriol (0.005%) for 3 weeks and then twice weekly for 9 weeks, for a complete cycle of treatment of 12 weeks |
| Control group, no estriol treatment | Active comparator | Procedure: vaginal surgeryProcedure: vaginal surgery |
Who may qualify
- Ages
- 56 to 63 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- genital dryness,
- irritation/burning/itching of vulvas or vagina
- decreased lubrication with sexual activity
- discomfort or pain with sexual activity
- decreased arousal, orgasm, desire
Key exclusion criteria (14 listed)
- previous surgeries for pelvic organ prolapse
- urinary incontinence
- usage of medication
- chronic medical illness
- body mass index (BMI) ≥ 35 kg/m2
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 |
|---|---|---|
| estriolStudy Group, treated with estriol Control Group, no drug treatment Both groups will undergo vaginal surgery for prolapse | Drug | Study Group on estriol vaginal gel |
| vaginal surgeryAlso: vaginal surgery for prolapseControl Group | Procedure or surgery | Control group, no estriol treatment, Study Group on estriol vaginal gel |
Primary outcome
Vaginal Health Indexes
Time frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
2 secondary outcomes
QoL and sexual function were investigated by the Short Form 36 (SF-36)
Time frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively
Time frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Results publication: PubMed 26079974Caruso S, Cianci S, Amore FF, Ventura B, Bambili E, Spadola S, Cianci A. Quality of life and sexual function of naturally postmenopausal women on an ultralow-concentration estriol vaginal gel. Menopause. 2016 Jan;23(1):47-54. doi: 10.1097/GME.0000000000000485.
- 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: No
Related trials for Genital Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Active, not recruiting
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Uterine Prolapse
Recruiting
Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
Prolapse; Female, Endometriosis-related Pain
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.
Antonio Cianci, Prof study chair
Policlinico Catania
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing estriol and vaginal surgery in people with Genital Prolapse, run by Salvatore Caruso.
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 14 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: status not confirmed, as of the sponsor's last update on 19 Sep 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Caruso, Prof (+390953781101, scaruso@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Health Indexes (time frame: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks). 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 NCT02906111, 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 19 Sep 2016.