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Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
This study has been completed.
Study NCT00160316   Information provided by Solvay Pharmaceuticals
First Received: September 9, 2005   Last Updated: March 11, 2008   History of Changes

September 9, 2005
March 11, 2008
April 2005
December 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00160316 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
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

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

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Postmenopause
Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
454
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Poland,   Romania,   Ukraine
 
NCT00160316
Gregor Eibes, Solvay Pharmaceuticals
S102.3.117, 2004-000227-15
Solvay Pharmaceuticals
 
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP