Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160316
First received: September 9, 2005
Last updated: March 11, 2008
Last verified: March 2008
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
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 |
|---|---|
| Experimental: 1 |
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 32 | |
| Katowice, Poland | |
| Site 36 | |
| Kraków, Poland | |
| Site 30 | |
| Kraków, Poland | |
| Site 35 | |
| 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
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Gregor Eibes, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00160316 History of Changes |
| Other Study ID Numbers: | S102.3.117, 2004-000227-15 |
| Study First Received: | September 9, 2005 |
| Last Updated: | March 11, 2008 |
| Health Authority: | Romania: State Institute for Drug Control |
Additional relevant MeSH terms:
|
Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Dydrogesterone Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate |
Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Estrogens Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 22, 2013