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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00160316
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 12, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Postmenopause Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 454 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
p.o. daily




Primary Outcome Measures :
  1. Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; [ Time Frame: 52 weeks ]
  3. 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 ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160316


Locations
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Croatia
Site 10
Zagreb, Croatia
Site 11
Zagreb, Croatia
Site 12
Zagreb, Croatia
Site 13
Zagreb, Croatia
Poland
Site 32
Katowice, Poland
Site 30
Kraków, Poland
Site 35
Kraków, Poland
Site 36
Kraków, Poland
Site 34
Lublin, Poland
Site 31
Miechów, Poland
Site 33
Warszawa, 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 20
Kiev, Ukraine
Site 21
Kiev, Ukraine
Site 22
Kiev, Ukraine
Site 23
Zaporozhye, Ukraine
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

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Responsible Party: Gregor Eibes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160316     History of Changes
Other Study ID Numbers: S102.3.117
2004-000227-15
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 12, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
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Estradiol
Polyestradiol phosphate
Dydrogesterone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins