Trials Sponsors Conditions Drugs Pricing

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

continuous combined estradiol and dydrogesteroneDrug

1 Mg Estradiol and 5 Mg Dydrogesterone

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
continuous combined estradiol and dydrogesterone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
continuous combined estradiol and dydrogesterone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

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

Sponsors & Collaborators

Solvay Pharmaceuticals
Industrylead

Study Sites (18)

Site 11

Zagreb, Croatia

Site 12

Zagreb, Croatia

Site 13

Zagreb, Croatia

Site 23

Cannes, France

Site 24

Cannes, France

Site 21

Montpellier, France

Site 22

Montpellier, France

Site 34

Katowice, Poland

MeSH Terms

Interventions

Dydrogesterone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

Global Clinical Director Solvay
Solvay Pharmaceuticals
STUDY DIRECTOR

Enrollment

391 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

A

B

C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (18)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

A

B

C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (18)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations