Pelvic Organ Prolapse (POP)NCT07854873

Vaginal Prasterone Versus Estriol in Women With Pelvic Floor Disorders

A study testing Prasterone (DHEA) and Estriol in people with Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), run by Poznan University of Medical Sciences at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
What is being tested?: Prasterone (DHEA) and Estriol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 sitePoland
Study dates: 1 Oct 2022to 31 Jan 2026
Phase: Interventional

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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult women aged 18 years or older.
Clinically diagnosed pelvic organ prolapse, POP-Q stage II-IV, or stress urinary incontinence, Stamey grade 2-3.
Scheduled for urogynecological surgery.
Received preoperative vaginal treatment with either prasterone or estriol.
Availability of baseline and post-treatment clinical data.
Completed quality-of-life questionnaires.

Who cannot join

Concomitant pelvic organ prolapse and stress urinary incontinence.
Incomplete treatment course.
Missing baseline or post-treatment clinical data.
Incomplete quality-of-life questionnaires.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Gynecology and Obstetrics Clinical Hospital, Poznan University of Medical Sciences
Poznan, Greater Poland Voivodeship, 60-535

Other trials in Poland

About this study

Official title: Short-Term Vaginal Estriol Versus Prasterone in Women With Pelvic Floor Disorders: A Prospective Non-Randomized Comparative Study of Symptoms and Quality of Life"

This prospective, non-randomized comparative study evaluated the effects of short-term vaginal treatment with prasterone or estriol in women with pelvic floor disorders who were awaiting urogynecological surgery. A total of 74 women were included, with 37 participants receiving vaginal prasterone and 37 receiving vaginal estriol. Treatment was administered before surgery for approximately 8 weeks. The study assessed changes in pelvic floor symptoms and quality of life using the WHOQOL-BREF questionnaire and symptom severity scales. The aim was to compare the effects of the two vaginal treatments on symptoms and quality of life before urogynecological surgery.

Read the detailed description

Women with pelvic floor disorders, including pelvic organ prolapse and/or stress urinary incontinence, who were scheduled for urogynecological surgery were prospectively enrolled. Participants received preoperative vaginal treatment with either prasterone or estriol according to the treatment protocol used at the study center. The study was non-randomized. Quality of life was evaluated using the WHOQOL-BREF questionnaire, and pelvic floor symptoms were assessed using symptom severity scales before and after treatment. The primary objective was to evaluate changes in quality of life and pelvic floor symptoms and to compare outcomes between the prasterone and estriol groups.

Conditions: Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Being tested: Prasterone (DHEA), Estriol
Keywords: prasterone, estriol, vaginal therapy
Medical subject headings: Pelvic Organ Prolapse, Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prasterone (DHEA)Drug
6.5 mg vaginally once daily for 8 weeks before urogynecological surgery.
EstriolDrug
Vaginal estriol (Oekolp forte) was administered once daily for 14 days, followed by twice-weekly administration for 8 weeks before urogynecological surgery. In participants with advanced pelvic organ prolapse, estriol cream was used when clinically indicated.

Study groups in NCT07854873
Study group	Role	What they receive
Arm1: Prasterone Group	Experimental	- Participants received vaginal prasterone 6.5 mg once daily for 8 weeks before urogynecological surgery. Receives: Drug: Prasterone (DHEA)
Arm2: Estriol Group	Active comparator	Participants received vaginal estriol according to the preoperative treatment regimen before urogynecological surgery. Receives: Drug: Estriol

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Quality of Life Measured by WHOQOL-BREF
Quality of life was assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF) questionnaire at baseline and after 8 weeks of vaginal treatment. The questionnaire evaluates four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. Changes from baseline were compared between the prasterone and estriol groups.
Measured: Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202231 Jan 2026

First posted2 Oct 2026
Study start1 Oct 2022
Primary completion31 Jan 2026
Study completion31 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pelvic Organ Prolapse (POP)Studies 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Participants were assigned to one of two parallel treatment groups receiving vaginal prasterone or vaginal estriol before urogynecological surgery.
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07854873
Sponsor's protocol ID: PRASTERONE-ESTRIOL-2026
Status last verified: Sep 2026
First submitted: 28 Sep 2026
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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