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Sponsored by: |
University of Messina |
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Information provided by: | University of Messina |
ClinicalTrials.gov Identifier: | NCT00453960 |
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.
Condition | Intervention | Phase |
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Endometrial Hyperplasia |
Dietary Supplement: Genivis Drug: Norethisterone Acetate Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Effect of Genistein on Endometrial Hyperplasia |
Enrollment: | 59 |
Study Start Date: | January 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Genistein: Experimental
Genistein 54 mg/day
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Dietary Supplement: Genivis
54 mg/day daily for 6 months
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Norethisterone Acetate: Active Comparator
Norethisterone Acetate 10mg/day
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Drug: Norethisterone Acetate
tablets 10mg/day from day 16 to 25 of menstruation
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Placebo: Placebo Comparator
Placebo tablets, daily
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Other: placebo
tablets daily for 6 months
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Although isoflavones alone (example: Genistein) have weak estrogenic effects on endometrial stromal and glandular cells, it was demonstrated, in several research efforts, that in the presence of E2 they act as antiestrogens. Considered that endometrial hyperplasia is due to strong and extended estrogenic stimulation, not offset by a proportionate amount of progesterone, we suppose that genistein could be therapeutic in these cases inducing a decrease of the hyperplasia and a change from the proliferative to a secretory phase of the endometrium.
Ages Eligible for Study: | 44 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino" | |
Messina, Italy, 98100 |
Study Director: | Rosario D'Anna, prof. | menopause centre |
Responsible Party: | University of Messina ( University of Messina ) |
Study ID Numbers: | Roberta Granese, MD, PhD |
Study First Received: | March 28, 2007 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00453960 History of Changes |
Health Authority: | Italy: National Institute of Health |
Endometrial hyperplasia Genistein Isoflavones dysfunctional uterine bleeding |
Anticarcinogenic Agents Estrogens Metrorrhagia Uterine Hemorrhage Contraceptive Agents Hormone Antagonists Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Uterine Diseases |
Hemorrhage Protein Kinase Inhibitors Hormones Genital Diseases, Female Hyperplasia Norethindrone Phytoestrogens Genistein Norethindrone acetate Endometrial Hyperplasia |
Anticarcinogenic Agents Molecular Mechanisms of Pharmacological Action Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Protein Kinase Inhibitors Genital Diseases, Female Pathologic Processes Norethindrone |
Therapeutic Uses Phytoestrogens Contraceptives, Oral, Synthetic Estrogens Uterine Diseases Enzyme Inhibitors Protective Agents Pharmacologic Actions Hyperplasia Estrogens, Non-Steroidal Genistein Norethindrone acetate Endometrial Hyperplasia |