Trials Sponsors Conditions Drugs Pricing

Conditions

Postmenopause

Outcome Measures

Primary Outcomes (1)

Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
52 weeks

Secondary Outcomes (3)

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 (domains: psychological, vasomotor, somatic, sexual, menstrual, androgenic): average score of the single items within the domain; QualiPause Inventory 7D: weighted sum score of the symptoms
52 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

Interventions

0.5 Mg Estradiol and 2.5 Mg DydrogesteroneDrug

p.o. daily

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

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

Grouped treatment entry
0.5 Mg Estradiol and 2.5 Mg 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+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Amenorrhoea for \>= 12 months.
Serum estradiol and FSH level within the postmenopausal range

Sponsors & Collaborators

Solvay Pharmaceuticals
Industrylead

Study Sites (22)

Site 10

Zagreb, Croatia

Site 11

Zagreb, Croatia

Site 12

Zagreb, Croatia

Site 13

Zagreb, Croatia

Site 32

Katowice, Poland

Site 30

Krakow, Poland

Site 35

Krakow, Poland

Site 36

Krakow, Poland

MeSH Terms

Interventions

EstradiolDydrogesterone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienesPregnanes

Study Officials

Global Clinical Director Solvay
Solvay Pharmaceuticals
STUDY DIRECTOR

Enrollment

454 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

1

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

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

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

1

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations