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Clinical Trials/ACTRN12610000563066
ACTRN12610000563066CompletedPhase 4

Estrogen treatment to induce endometrial regeneration in postmenopausal women scheduled to undergo hysterectomy, to obtain endometrial mesenchymal stem cells.

Professor CAroline Gargett0 sites15 target enrollmentStarted: July 13, 2010Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
15
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This phase IV clinical trial showed that endometrial mesenchymal stem cells could be harvested from postmenopausal endometrium 8 weeks after women took 2 mg Progynova (estrogen) daily by tablet to regenerate their thin endometrium. This means that postmenopausal women who have no contraindication for taking estrogen can use their endometrial mesenchymal stem cells for a cell based therapy for pelvic organ prolapse we are developing.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
45 Years to 69 Years (—)
Sex
Female

Inclusion Criteria

  • •Postmenopausal women who have not had a period for >12 months who are scheduled to undergo hysterectomy for treatment of their underlying clinical condition, usually for pelvic organ prolapse but may include other indications (eg fibroids, menorrhagia).
  • •Women already on hormone replacement therapy will be recruited and if appropriate, the estrogen component will be changed to estradiol valerate without a progestogen.

Exclusion Criteria

  • •Undiagnosed abnormal genital bleeding.
  • •Known, suspected, or history of cancer of the breast..
  • •Known or suspected estrogen-dependent neoplasia.
  • •Current or past history of deep vein thrombosis, pulmonary embolism, or a known coagulopathy.a history of these conditions.
  • •Active or recent (within the past year) arterial thromboembolic disease (for example, stroke, myocardial infarction); uncontrolled hypertension.
  • •Liver dysfunction or disease.
  • •Known hypersensitivity to any of the ingredients in Progynova.
  • •Known or suspected pregnancy.

Investigators

Sponsor
Professor CAroline Gargett

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