Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse

PHASE4CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 2, 2017

Primary Completion Date

August 27, 2020

Study Completion Date

August 27, 2020

Conditions
Pelvic Organ Prolapse
Interventions
DRUG

Linoladiol Estradiol

"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"

OTHER

Placebo vaginal cream

"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"

Trial Locations (2)

1090

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

3430

Department of Obstetrics and Gynecology, University of Tulln, Tulln

All Listed Sponsors
lead

Medical University of Vienna

OTHER

NCT03779633 - Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse | Biotech Hunter | Biotech Hunter