Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160316

Purpose

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

Condition	Intervention	Phase
Postmenopause	Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Dydrogesterone Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2); [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	454
Study Start Date:	April 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone p.o. daily

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160316

Locations

Croatia
Site 10
Zagreb, Croatia
Site 11
Zagreb, Croatia
Site 12
Zagreb, Croatia
Site 13
Zagreb, Croatia
Poland
Site 30
Kraków, Poland
Site 36
Kraków, Poland
Site 32
Katowice, Poland
Site 33
Warszawa, Poland
Site 34
Lublin, Poland
Site 35
Kraków, Poland
Site 31
Miechów, Poland
Romania
Site 40
Bucharest, Romania
Site 41
Bucharest, Romania
Site 42
Bucharest, Romania
Site 43
Bucharest, Romania
Site 44
Bucharest, Romania
Site 45
Bucharest, Romania
Ukraine
Site 24
Donetsk, Ukraine
Site 21
Kiev, Ukraine
Site 22
Kiev, Ukraine
Site 23
Zaporozhye, Ukraine
Site 20
Kiev, Ukraine

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Gregor Eibes )
Study ID Numbers:	S102.3.117, 2004-000227-15
Study First Received:	September 9, 2005
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00160316 History of Changes
Health Authority:	Romania: State Institute for Drug Control

Study placed in the following topic categories:

Estrogens
Benzoates
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists

Estradiol 17 beta-cypionate
Hormones
Estradiol
Dydrogesterone
Estradiol 3-benzoate
Progestins
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Estradiol 17 beta-cypionate

Hormones
Estradiol
Pharmacologic Actions
Dydrogesterone
Therapeutic Uses
Estradiol 3-benzoate
Progestins
Polyestradiol phosphate

ClinicalTrials.gov processed this record on July 02, 2009