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

Postmenopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160316
• Other study ID #: S102.3.117
• Secondary ID: 2004-000227-15
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 11, 2008
• Start date: April 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
p.o. daily

Locations

Country	Name	City	State
Croatia	Site 10	Zagreb
Croatia	Site 11	Zagreb
Croatia	Site 12	Zagreb
Croatia	Site 13	Zagreb
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
Romania	Site 40	Bucharest
Romania	Site 41	Bucharest
Romania	Site 42	Bucharest
Romania	Site 43	Bucharest
Romania	Site 44	Bucharest
Romania	Site 45	Bucharest
Ukraine	Site 24	Donetsk
Ukraine	Site 20	Kiev
Ukraine	Site 21	Kiev
Ukraine	Site 22	Kiev
Ukraine	Site 23	Zaporozhye

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Croatia,  Poland,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period		52 weeks	Yes
Secondary	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	Yes
Secondary	Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;		52 weeks	Yes
Secondary	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	No