Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

Postmenopause Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251082
• Other study ID #: S102.3.119
• Secondary ID: 2004-00215-25
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2005
• Last updated: March 11, 2008
• Start date: December 2005
• Est. completion date: October 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

To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Non-hysterectomised postmenopausal women

• Amenorrhoea for >= 12 months

• Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range

Exclusion Criteria:

• Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication

• Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).

• Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness >= 5 mm (double layer) by transvaginal ultrasound.

• The presence of an endometrial polyp at baseline.

• Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).

• Estradiol pellet/implant therapy during the past 6 months.

• Previous systemic unopposed estrogen replacement therapy over 6 months or more.

• History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• continuous combined estradiol and dydrogesterone
0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
• continuous combined estradiol and dydrogesterone
1 Mg Estradiol and 5 Mg Dydrogesterone
• Placebo
Placebo

Locations

Country	Name	City	State
Croatia	Site 11	Zagreb
Croatia	Site 12	Zagreb
Croatia	Site 13	Zagreb
France	Site 23	Cannes
France	Site 24	Cannes
France	Site 21	Montpellier
France	Site 22	Montpellier
Poland	Site 34	Katowice
Poland	Site 33	Kraków
Poland	Site 32	Lódz
Poland	Site 31	Warszawa
Romania	Site 41	Bucharest
Romania	Site 42	Bucharest
Romania	Site 44	Bucharest
Romania	Site 43	Craiova, Jud.Dolj
Russian Federation	Site 51	Moscow
Russian Federation	Site 52	Moscow
Russian Federation	Site 53	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Croatia,  France,  Poland,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the number of moderate to severe hot flushes from baseline to week 13		12 weeks	No
Secondary	Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;		12 weeks	No
Secondary	Change in the Menopause Rating Scale from baseline to weeks 4 and 13;		52 weeks	No
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	No
Secondary	Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;		52 weeks	No
Secondary	QualiPause Inventory 7D: weighted sum score of the symptoms		52 weeks	No