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Genistein and Endometrial Hyperplasia

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ClinicalTrials.gov Identifier: NCT00453960
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
University of Messina

Brief Summary:
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.

Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia Dietary Supplement: Genivis Drug: Norethisterone Acetate Other: placebo Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Genistein on Endometrial Hyperplasia
Study Start Date : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Genistein

Arm Intervention/treatment
Experimental: Genistein
Genistein 54 mg/day
Dietary Supplement: Genivis
54 mg/day daily for 6 months
Other Name: Fosteum

Active Comparator: Norethisterone Acetate
Norethisterone Acetate 10mg/day
Drug: Norethisterone Acetate
tablets 10mg/day from day 16 to 25 of menstruation

Placebo Comparator: Placebo
Placebo tablets, daily
Other: placebo
tablets daily for 6 months




Primary Outcome Measures :
  1. Recovery from endometrial hyperplasia [ Time Frame: 3-6 months ]

Secondary Outcome Measures :
  1. Differential expression of ER-a and ER-b in endometrial specimens [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   44 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women
  • 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:

  • All the other conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453960


Locations
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Italy
Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"
Messina, Italy, 98100
Sponsors and Collaborators
University of Messina
Investigators
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Study Director: Rosario D'Anna, prof. menopause centre

Publications of Results:
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Responsible Party: University of Messina
ClinicalTrials.gov Identifier: NCT00453960     History of Changes
Other Study ID Numbers: Roberta Granese, MD, PhD
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008

Keywords provided by University of Messina:
Endometrial hyperplasia
Genistein
Isoflavones
dysfunctional uterine bleeding

Additional relevant MeSH terms:
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Hyperplasia
Endometrial Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Genistein
Norethindrone
Norethindrone Acetate
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents