Clinical trial NCT00160316: Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopause
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 454
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
timeFrame: 52 weeks
Secondary outcomes:
measure: Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);
timeFrame: 52 weeks
measure: Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
timeFrame: 52 weeks
measure: 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
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Site 10
city: Zagreb
country: Croatia
facility: Site 11
city: Zagreb
country: Croatia
facility: Site 12
city: Zagreb
country: Croatia
facility: Site 13
city: Katowice
country: Poland
facility: Site 32
city: Kraków
country: Poland
facility: Site 30
city: Kraków
country: Poland
facility: Site 35
city: Kraków
country: Poland
facility: Site 36
city: Lublin
country: Poland
facility: Site 34
city: Miechów
country: Poland
facility: Site 31
city: Warszawa
country: Poland
facility: Site 33
city: Bucharest
country: Romania
facility: Site 40
city: Bucharest
country: Romania
facility: Site 41
city: Bucharest
country: Romania
facility: Site 42
city: Bucharest
country: Romania
facility: Site 43
city: Bucharest
country: Romania
facility: Site 44
city: Bucharest
country: Romania
facility: Site 45
city: Donetsk
country: Ukraine
facility: Site 24
city: Kiev
country: Ukraine
facility: Site 20
city: Kiev
country: Ukraine
facility: Site 21
city: Kiev
country: Ukraine
facility: Site 22
city: Zaporozhye
country: Ukraine
facility: Site 23
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: