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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251082
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : March 12, 2008
Information provided by:
Solvay Pharmaceuticals

Brief 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

Condition or disease Intervention/treatment Phase
Postmenopause Drug: continuous combined estradiol and dydrogesterone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
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
Study Start Date : December 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The change in the number of moderate to severe hot flushes from baseline to week 13 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in the Menopause Rating Scale from baseline to weeks 4 and 13; [ Time Frame: 52 weeks ]
  3. 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 ]
  4. Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; [ Time Frame: 52 weeks ]
  5. QualiPause Inventory 7D: weighted sum score of the symptoms [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251082

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Sponsors and Collaborators
Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

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Responsible Party: Gregor Eibes, Solvay Pharmaceuticals Identifier: NCT00251082    
Other Study ID Numbers: S102.3.119
First Posted: November 9, 2005    Key Record Dates
Last Update Posted: March 12, 2008
Last Verified: March 2008
Keywords provided by Solvay Pharmaceuticals:
hormone replacement
vasomotoric symptoms
bleeding pattern
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female