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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00251082
First received: November 8, 2005
Last updated: March 11, 2008
Last verified: March 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Postmenopause
 Drug: continuous combined estradiol and dydrogesterone
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • The change in the number of moderate to severe hot flushes from baseline to week 13 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in the Menopause Rating Scale from baseline to weeks 4 and 13; [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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: No ]
  • 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: No ]
  • QualiPause Inventory 7D: weighted sum score of the symptoms [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 391
Study Start Date: December 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: continuous combined estradiol and dydrogesterone
0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
Active Comparator: B Drug: continuous combined estradiol and dydrogesterone
1 Mg Estradiol and 5 Mg Dydrogesterone
Placebo Comparator: C Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251082

Locations
Croatia
Site 11
Zagreb, Croatia
Site 12
Zagreb, Croatia
Site 13
Zagreb, Croatia
France
Site 23
Cannes, France
Site 24
Cannes, France
Site 21
Montpellier, France
Site 22
Montpellier, France
Poland
Site 34
Katowice, Poland
Site 33
Kraków, Poland
Site 32
Lódź, Poland
Site 31
Warszawa, Poland
Romania
Site 44
Bucharest, Romania
Site 41
Bucharest, Romania
Site 42
Bucharest, Romania
Site 43
Craiova, Jud.Dolj, Romania
Russian Federation
Site 51
Moscow, Russian Federation
Site 52
Moscow, Russian Federation
Site 53
Moscow, Russian Federation
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: NCT00251082     History of Changes
Other Study ID Numbers: S102.3.119, 2004-00215-25
Study First Received: November 8, 2005
Last Updated: March 11, 2008
Health Authority: Romania: State Institute for Drug Control

Keywords provided by Solvay Pharmaceuticals:
hormone replacement
vasomotoric symptoms
bleeding pattern

Additional relevant MeSH terms:
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 19, 2013