NCT00251082

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Geographic Reach
5 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

Enrollment Period

1.8 years

First QC Date

November 8, 2005

Last Update Submit

March 11, 2008

Conditions

Postmenopause

Keywords

hormone replacementvasomotoric symptomsbleeding pattern

Outcome Measures

Primary Outcomes (1)

  • The change in the number of moderate to severe hot flushes from baseline to week 13

    12 weeks

Secondary Outcomes (5)

  • 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

Study Arms (3)

A

EXPERIMENTAL
Drug: continuous combined estradiol and dydrogesterone

B

ACTIVE COMPARATOR
Drug: continuous combined estradiol and dydrogesterone

C

PLACEBO COMPARATOR
Drug: Placebo

Interventions

continuous combined estradiol and dydrogesteroneDRUG

0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

A
PlaceboDRUG

Placebo

C

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Site 11

Zagreb, Croatia

Location

Site 12

Zagreb, Croatia

Location

Site 13

Zagreb, Croatia

Location

Site 23

Cannes, France

Location

Site 24

Cannes, France

Location

Site 21

Montpellier, France

Location

Site 22

Montpellier, France

Location

Site 34

Katowice, Poland

Location

Site 33

Krakow, Poland

Location

Site 32

Lódź, Poland

Location

Site 31

Warsaw, Poland

Location

Site 41

Bucharest, Romania

Location

Site 42

Bucharest, Romania

Location

Site 44

Bucharest, Romania

Location

Site 43

Craiova, Jud.Dolj, Romania

Location

Site 51

Moscow, Russia

Location

Site 52

Moscow, Russia

Location

Site 53

Moscow, Russia

Location

MeSH Terms

Interventions

Dydrogesterone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 9, 2005

Study Start

December 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

FR(4)PL(4)RU(3)RO(4)CR(3)