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

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: November 8, 2005
Last updated: March 11, 2008
Last verified: March 2008
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:

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 ]

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 ]
  • Change in the Menopause Rating Scale from baseline to weeks 4 and 13; [ Time Frame: 52 weeks ]
  • 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 ]
  • Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; [ Time Frame: 52 weeks ]
  • QualiPause Inventory 7D: weighted sum score of the symptoms [ Time Frame: 52 weeks ]

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


Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00251082

Site 11
Zagreb, Croatia
Site 12
Zagreb, Croatia
Site 13
Zagreb, Croatia
Site 23
Cannes, France
Site 24
Cannes, France
Site 21
Montpellier, France
Site 22
Montpellier, France
Site 34
Katowice, Poland
Site 33
Kraków, Poland
Site 32
Lódź, Poland
Site 31
Warszawa, Poland
Site 41
Bucharest, Romania
Site 42
Bucharest, Romania
Site 44
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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Gregor Eibes, Solvay Pharmaceuticals Identifier: NCT00251082     History of Changes
Other Study ID Numbers: S102.3.119
Study First Received: November 8, 2005
Last Updated: March 11, 2008

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

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins processed this record on September 25, 2017