Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2007-01-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Genistein
Genistein 54 mg/day
Genivis
54 mg/day daily for 6 months
Norethisterone Acetate
Norethisterone Acetate 10mg/day
Norethisterone Acetate
tablets 10mg/day from day 16 to 25 of menstruation
Placebo
Placebo tablets, daily
placebo
tablets daily for 6 months
Interventions
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Genivis
54 mg/day daily for 6 months
Norethisterone Acetate
tablets 10mg/day from day 16 to 25 of menstruation
placebo
tablets daily for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> = 44 years
* Dysfunctional uterine bleeding
* No treatment with other hormonal drugs (estrogen, progesterone)
* No local or general pathology negatively influenced by administration of genistein or progesterone
* No intrauterine pathologies (polyps, myomas)
* A "non atypical endometrial hyperplasia", confirmed by hysteroscopy with biopsy and histological examination
Exclusion Criteria
44 Years
55 Years
FEMALE
No
Sponsors
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University of Messina
OTHER
Responsible Party
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University of Messina
Principal Investigators
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Rosario D'Anna, prof.
Role: STUDY_DIRECTOR
menopause centre
Locations
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Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"
Messina, , Italy
Countries
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References
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Kayisli UA, Aksu CA, Berkkanoglu M, Arici A. Estrogenicity of isoflavones on human endometrial stromal and glandular cells. J Clin Endocrinol Metab. 2002 Dec;87(12):5539-44. doi: 10.1210/jc.2002-020716.
Other Identifiers
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Roberta Granese, MD, PhD
Identifier Type: -
Identifier Source: org_study_id