NCT02906111

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

August 24, 2016

Last Update Submit

September 14, 2016

Conditions

Genital Prolapse

Keywords

EstriolProlapseQuality of lifeVaginal healthVaginal surgery

Outcome Measures

Primary Outcomes (1)

  • Vaginal Health Indexes

    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)

    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

    vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks

Study Arms (2)

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

Drug: estriolProcedure: vaginal surgery

Control group, no estriol treatment

ACTIVE COMPARATOR

Procedure: vaginal surgery

Procedure: vaginal surgery

Interventions

estriolDRUG

Study Group, treated with estriol Control Group, no drug treatment Both groups will undergo vaginal surgery for prolapse

Study Group on estriol vaginal gel
vaginal surgeryPROCEDURE

Control Group

Also known as: vaginal surgery for prolapse
Control group, no estriol treatmentStudy Group on estriol vaginal gel

Eligibility Criteria

Age56 Years - 63 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26079974RESULT

  • 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.

    PMID: 37431855DERIVED

MeSH Terms

Conditions

Prolapse

Interventions

Estriol

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Antonio Cianci, Prof

    Policlinico Catania

    STUDY CHAIR

Central Study Contacts

Salvatore Caruso, Prof

CONTACT

+390953781101scaruso@unict.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Gynecology, Clinic of Gynecology

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 19, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 19, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share