NCT00160316

Brief Summary

The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
454

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2005

Typical duration for phase_3

Geographic Reach
4 countries

22 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

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

Enrollment Period

2.7 years

First QC Date

September 9, 2005

Last Update Submit

March 11, 2008

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

1

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
  • Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness \< 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium

You may not qualify if:

  • Previous systemic unopposed estrogen replacement therapy over 6 months or more.
  • Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy.
  • History or presence of an estrogen dependent neoplasia (including breast- cancer).
  • 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 (22)

Site 10

Zagreb, Croatia

Location

Site 11

Zagreb, Croatia

Location

Site 12

Zagreb, Croatia

Location

Site 13

Zagreb, Croatia

Location

Site 32

Katowice, Poland

Location

Site 30

Krakow, Poland

Location

Site 35

Krakow, Poland

Location

Site 36

Krakow, Poland

Location

Site 34

Lublin, Poland

Location

Site 31

Miechów, Poland

Location

Site 33

Warsaw, Poland

Location

Site 40

Bucharest, Romania

Location

Site 41

Bucharest, Romania

Location

Site 42

Bucharest, Romania

Location

Site 43

Bucharest, Romania

Location

Site 44

Bucharest, Romania

Location

Site 45

Bucharest, Romania

Location

Site 24

Donetsk, Ukraine

Location

Site 20

Kiev, Ukraine

Location

Site 21

Kiev, Ukraine

Location

Site 22

Kiev, Ukraine

Location

Site 23

Zaporizhzhya, Ukraine

Location

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

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 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

CR(4)PL(7)RO(6)UA(5)