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Completed

NCT Number: NCT00160316

Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.

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Key information

Conditions

Postmenopause

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Site 10, 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

  • Amenorrhoea for >= 12 months.
  • Serum estradiol and FSH level within the postmenopausal range
  • Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness < 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium

Exclusion criteria

  • Previous systemic unopposed estrogen replacement therapy over 6 months or more.
  • Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy.
  • History or presence of an estrogen dependent neoplasia (including breast- cancer).
  • History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin.

Treatment and study plan

0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

Drug

p.o. daily

Primary outcomes

  1. Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period

    Time frame: 52 weeks

Secondary outcomes

  1. 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

  2. Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;

    Time frame: 52 weeks

  3. QualiPause Inventory (domains: psychological, vasomotor, somatic, sexual, menstrual, androgenic): average score of the single items within the domain; 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

Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 12, 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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