Endometrial HyperplasiaPhase 2NCT00453960
Genistein and Endometrial Hyperplasia
A Phase 2 study testing Genivis and Norethisterone Acetate in people with Endometrial Hyperplasia, run by University of Messina at 1 site in Italy.
Trial summary
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women. Read more about this study
- Who is it for?
- Ages 44 to 55 years, women only
- Conditions the study is for
- Endometrial Hyperplasia
- What is being tested?
- Genivis and Norethisterone Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- All the other conditions
Trial locations and contacts
1 site in 1 country.
Italy1 site
Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"
Messina, 98100
About this study
Official title: Effect of Genistein on Endometrial Hyperplasia
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.
Read the 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.
- Conditions
- Endometrial Hyperplasia
- Being tested
- Genivis, Norethisterone Acetate, placebo
- Keywords
- Endometrial hyperplasia, Genistein, Isoflavones, dysfunctional uterine bleeding
- Medical subject headings
- Endometrial Hyperplasia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenivisDietary supplement
Also called Fosteum
54 mg/day daily for 6 months
Norethisterone AcetateDrug
tablets 10mg/day from day 16 to 25 of menstruation
placeboOther
tablets daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Genistein | Experimental | Genistein 54 mg/day Receives: Dietary Supplement: Genivis |
| Norethisterone Acetate | Active comparator | Norethisterone Acetate 10mg/day Receives: Drug: Norethisterone Acetate |
| Placebo | Placebo comparator | Placebo tablets, daily Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from endometrial hyperplasia
Measured: 3-6 months
Secondary outcomes (1)
Differential expression of ER-a and ER-b in endometrial specimens
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Investigators
- Rosario D'Anna, prof., Study director, menopause centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453960
- Sponsor's protocol ID
- Roberta Granese, MD, PhD
- Status last verified
- Dec 2008
- First submitted
- 28 Mar 2007
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12466350
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genistein on Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT00453960
- Acronym / sponsor ID
- Roberta Granese, MD, PhD
- Conditions
- Endometrial Hyperplasia
- Keywords
- Endometrial hyperplasia, Genistein, Isoflavones, dysfunctional uterine bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genistein | Experimental | Dietary Supplement: GenivisGenistein 54 mg/day |
| Norethisterone Acetate | Active comparator | Drug: Norethisterone AcetateNorethisterone Acetate 10mg/day |
| Placebo | Placebo comparator | Other: placeboPlacebo tablets, daily |
Who may qualify
- Ages
- 44 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- All the other conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenivisAlso: Fosteum54 mg/day daily for 6 months | Dietary supplement | Genistein |
| Norethisterone Acetatetablets 10mg/day from day 16 to 25 of menstruation | Drug | Norethisterone Acetate |
| placebotablets daily for 6 months | Other | Placebo |
Primary outcome
Recovery from endometrial hyperplasia
Time frame: 3-6 months
1 secondary outcome
Differential expression of ER-a and ER-b in endometrial specimens
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2008.
- Results publication: PubMed 12466350Kayisli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosario D'Anna, prof. study director
menopause centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genivis and Norethisterone Acetate in people with Endometrial Hyperplasia, run by University of Messina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery from endometrial hyperplasia (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2008.