PREOPERATIVE LOCALLY APPLIED OESTROGEN IN POSTMENOPAUSAL WOMEN WITH PELVIC ORGAN PROLAPSE: INFLUENCE ON SUBJECTIVE AND OBJECTIVE PARAMETERS

PREOPERATIVE LOCALLY APPLIED OESTROGEN IN POSTMENOPAUSAL WOMEN WITH PELVIC ORGAN PROLAPSE: CHANGES IN SUBJECTIVE AND OBJECTIVE OUTCOME: A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000410-30-AT

Enrollment

120

Registered

2016-10-19

Start date

2016-12-01

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse

Interventions

Trade Name: Linoladiol Estradiol Emulsion Product Name: Linoladiol Emulsion Pharmaceutical Form: Vaginal cream INN or Proposed INN: ESTRADIOL HEMIHYDRATE CAS Number: 35380-71-3 Current Sponsor code: 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Postmenopausal women • Able to read, understand and sign informed consent • Able to apply a vaginal cream • Symptomatic pelvic organ prolapse • Planned and indicated for surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective • To demonstrate treatment efficacy of preoperative vaginally administered oestrogen in postmenopausal women with symptomatic pelvic organ prolapse in comparison to placebo, measured by a subjective questionnaire ;Secondary Objective: Secondary Objectives • To assess effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo • To assess differences in tissue operability between the two groups assessed by the surgeon • To assess possible differences regarding subjective and objective outcome parameters between intervention and placebo-group 3 months after operation ;Primary end point(s): Improvement of prolapse specific symptoms after preoperative treatment;Timepoint(s) of evaluation of this end point: after treatment of 6 weeks	—

Measure

Time frame

Main Objective: Primary Objective • To demonstrate treatment efficacy of preoperative vaginally administered oestrogen in postmenopausal women with symptomatic pelvic organ prolapse in comparison to placebo, measured by a subjective questionnaire ;Secondary Objective: Secondary Objectives • To assess effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo • To assess differences in tissue operability between the two groups assessed by the surgeon • To assess possible differences regarding subjective and objective outcome parameters between intervention and placebo-group 3 months after operation ;Primary end point(s): Improvement of prolapse specific symptoms after preoperative treatment;Timepoint(s) of evaluation of this end point: after treatment of 6 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Questionnaire domaine POP (POP score) at 3 months follow up, Other domains of the questionnaire (xxxxx) (baseline, 6 weeks, 3 months), POP-Q Score (baseline, 6 weeks, 3 months), postoperative variables;Timepoint(s) of evaluation of this end point: 6 weeks and 3 months after treatment	—

Countries

Austria

Contacts

Public ContactUrogynecological Department

Medical University of Vienna, Department of Obstetrics and Gynecology

0043140400 29620

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026