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Completed

NCT Number: NCT00251082

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

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

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Key information

Conditions

Postmenopause

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Site 11, Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

continuous combined estradiol and dydrogesterone

Drug

0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

Placebo

Drug

Placebo

Primary outcomes

  1. The change in the number of moderate to severe hot flushes from baseline to week 13

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 9, 2005
Registry last updated
Mar 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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