Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00251082

Enrollment

391

Registered

2005-11-09

Start date

2005-12-31

Completion date

2007-10-31

Last updated

2008-03-12

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

Conditions

Postmenopause

Keywords

hormone replacement, vasomotoric symptoms, bleeding pattern

Brief summary

To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

Interventions

DRUGcontinuous combined estradiol and dydrogesterone

0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Non-hysterectomised postmenopausal women * Amenorrhoea for \>= 12 months * Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range

Exclusion criteria

* Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication * Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma). * Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness \>= 5 mm (double layer) by transvaginal ultrasound. * The presence of an endometrial polyp at baseline. * Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1). * Estradiol pellet/implant therapy during the past 6 months. * Previous systemic unopposed estrogen replacement therapy over 6 months or more. * History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin

Design outcomes

Primary

Measure	Time frame
The change in the number of moderate to severe hot flushes from baseline to week 13	12 weeks

Secondary

Measure	Time frame
Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;	12 weeks
Change in the Menopause Rating Scale from baseline to weeks 4 and 13;	52 weeks
Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);	52 weeks
Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;	52 weeks
QualiPause Inventory 7D: weighted sum score of the symptoms	52 weeks

Countries

Croatia, France, Poland, Romania, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026