AzTrials
AzTrials

Pelvic Organ ProlapsePhase 4NCT03779633

Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse

A Phase 4 study testing Linoladiol Estradiol in people with Pelvic Organ Prolapse, run by Medical University of Vienna at 2 sites in Austria.

Completed

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

Official record
Search all trials

Trial summary

Introduction With increasing age the incidence of pelvic organ prolapse (POP) rises and will increase substantially in the future according to forecasting studies. It is possible that oestrogens, alone or in combination with other forms of therapy, may assist in the management of POP by increasing collagen synthesis… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pelvic Organ Prolapse
What is being tested?
Linoladiol Estradiol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesAustria
Study dates
2 Feb 2017to 27 Aug 2020
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women
  • Able to read, understand and sign informed consent
  • Able to apply a vaginal cream
  • Symptomatic pelvic organ prolapse with planned and indicated prolapse surgical repair

Who cannot join

  • Suspicion or history of breast cancer or other oestrogen responsive malignancies (endometrial cancer)
  • unexplained abnormal vaginal bleeding
  • history of deep vein thrombosis
  • inherited or acquired blood clotting disorders (eg, APC resistance, Antithrombin III deficiency)
  • transient ischaemic attack, myo- cardial infarction or ischaemic heart disease
  • Hypersensitivity to oestrogen
  • Unable to read and sign informed consent

Trial locations and contacts

2 sites in 1 country.

Austria2 sites

  • Department of Obstetrics and Gynecology, University of Tulln

    Tulln, 3430

  • Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Preoperative Locally Applied Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse: Changes in Subjective and Objective Outcome - a Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study

Introduction With increasing age the incidence of pelvic organ prolapse (POP) rises and will increase substantially in the future according to forecasting studies. It is possible that oestrogens, alone or in combination with other forms of therapy, may assist in the management of POP by increasing collagen synthesis and thereby improving the strength of the weakened vaginal epithelium. Yet, studies investigating the effect of topical oestrogen and its impact on POP associated symptoms, both self-reported improvement and observations of objective improvement, are lacking.

Objective To evaluate the subjective efficacy concerning prolapse associated complaints measured by the German pelvic floor questionnaire (domain POP: POP-score) after preoperative use of local oestrogen compared to preoperative placebo treatment in postmenopausal women with symptomatic pelvic organ prolapse. Further variables of interest are POP-score after 3 months, differences regarding the objective prolapse quantification system (POP-Q), surgical outcome and tissue operability assessed by the surgeon.

Methods In this prospective, randomized, double-blind, placebo-controlled, multicenter study the investigators aim to include 120 postmenopausal women with symptomatic pelvic organ prolapse and indicated operative procedure. An analysis of covariance will be computed with the depending variable POP-score after 6 weeks and the independent variables group (verum versus placebo) and Pop-Score at baseline.

Being tested
Linoladiol Estradiol, Placebo vaginal cream
Keywords
Local Oestrogen
Medical subject headings
Pelvic Organ Prolapse

What participants receive

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

  • Linoladiol EstradiolDrug

    Also called Montavit ATC Code G03CA03

    Linoladiol Estradiol Initial dose (week 1): 1 application (2g Linoladiol = 0.2mg Estradiol) every day for the first week Maintenance dose 1 (week 2) : 1 application (2g Linoladiol = 0.2mg Estradiol) every 48 hours the following week.

    Maintenance dose 2 (week 3-6): 1 application (2g Linoladiol = 0.2mg Estradiol) twice per week the following 4 weeks.

    Route of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks

  • Placebo vaginal creamOther

    Initial dose (week 1): 1 application every day for the first week Maintenance dose 1 (week 2) : 1 application every 48 hours the following week.

    Maintenance dose 2 (week 3-6): 1 application twice per week the following 4 weeks.

    Route of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks

Study groups in NCT03779633
Study groupRoleWhat they receive
Linoladiol EstradiolExperimentalLinoladiol Estradiol cream 6 weeks before surgery of pelvic organ prolapse
Receives: Drug: Linoladiol Estradiol
PlaceboPlacebo comparatorPlacebo cream 6 weeks before surgery of pelvic organ prolapse
Receives: Other: Placebo vaginal cream

What is being measured

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

  1. subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire)

    treatment efficacy of preoperative vaginally administered oestrogen in postmenopausal women with symptomatic pelvic organ prolapse in comparison to placebo, measured by a subjective questionnaire. 42 questions. Range 0 to 3 points for each question. Lower values represent a better outcome

    Measured: change from baseline POP Score at 6 weeks after treatment

Secondary outcomes (9)

  1. operative time in minutes

    effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo

    Measured: up to 1 week postoperative

  2. length of stay in days

    effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo

    Measured: up to 1 week postoperative

  3. intraoperative blood loss in ml

    effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo

    Measured: up to 1 week postoperative

  4. blood circulation of the tissue (good, regular, scarce, no blood circulation)

    differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation

    Measured: on day of surgery

  5. separability of the tissue layers (good, regular, scarce, not possible)

    differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation

    Measured: on day of surgery

  6. easy separation from the bladder (yes/no)

    differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation

    Measured: on day of surgery

  7. easy opening of the Douglas cavity (Yes/no)

    differences in tissue operability between the two groups assessed by means of a questionnaire which is filled in by the surgeon after the operation

    Measured: on day of surgery

  8. subjective (all domains of the pelvic floor questionnaire) outcome 3 months postoperative

    possible differences regarding subjective outcome parameters between intervention and placebo-group 3 months after operation. 42 questions. Range 0 to 3 points for each question. Lower values represent a better outcome.

    Measured: 3 months postoperative

  9. objective (POP-Q score) outcome 3 months postoperative

    possible differences regarding objective outcome parameters between intervention and placebo-group 3 months after operation. POP-Q Score (Score between 0 and 4). The POP- quantification system consists of six defined points of measurement (Aa, Ba, C,D,Ap,Bp) and three other landmarks (GH,TVL, PB). Each is measured in centimeters above the hymen (negative number) or below the hymen (positive number).

    Measured: 3 months postoperative

Timeline

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

  1. First posted19 Dec 2018
  2. Study start2 Feb 2017
  3. Primary completion27 Aug 2020
  4. Study completion27 Aug 2020

Resources

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
Model description
Double-blind, Placebo-controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03779633
Sponsor's protocol ID
EstrogenPOP
Status last verified
Nov 2020
First submitted
29 Jul 2018
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Weber MA, Kleijn MH, Langendam M, Limpens J, Heineman MJ, Roovers JP. Local Oestrogen for Pelvic Floor Disorders: A Systematic Review. PLoS One. 2015 Sep 18;10(9):e0136265. doi: 10.1371/journal.pone.0136265. eCollection 2015.

    PubMed 26383760

  • Rahn DD, Good MM, Roshanravan SM, Shi H, Schaffer JI, Singh RJ, Word RA. Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3728-36. doi: 10.1210/jc.2014-1216. Epub 2014 Jun 20.

    PubMed 24947034

  • 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

  • European Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):244-271. doi: 10.1097/SPV.0000000000001172. No abstract available.

    PubMed 35443258

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Linoladiol Estradiol in people with Pelvic Organ Prolapse, run by Medical University of Vienna at 2 sites in Austria.

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 4 inclusion and 7 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. 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. 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?

subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire) (time frame: change from baseline POP Score at 6 weeks after treatment). 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 NCT03779633, which also lists 4 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 17 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in