Endometrial HyperplasiaPhase 2NCT00919919
Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
A Phase 2 study testing progesterone and activella in people with Endometrial Hyperplasia and Endometrial Cancer, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Endometrial Hyperplasia, Endometrial Cancer
- What is being tested?
- progesterone and activella
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Nov 2010
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
- Women with an intact uterus.
- No menses within the 12 months preceding screening visit and /or FSH >30 IU/L.
- Endometrial thickness ≤ 5 mm.
Who cannot join
- Submucosal fibroid/s that applying pressure and affecting endometrial thickness
- Other medication that could affect estrogenic state.
Trial locations and contacts
1 site in 1 country.
Aviva Kaplan contact
Israel1 site
Rabin Medical Center Beilinson Hospital
Petah Tikva
Aviva kaplan, 972-50-5511591
Boris kaplan, prof
About this study
Official title: Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
Read the detailed description
Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.
- Conditions
- Endometrial Hyperplasia, Endometrial Cancer
- Being tested
- progesterone, activella
- Keywords
- menopause, Endometrial Thickness, progesterone
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesteroneDrug
Also called Endometrin
Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
activellaDrug
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
| Study group | Role | What they receive |
|---|---|---|
| Progesterone vaginal tablet | Experimental | Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally. Receives: Drug: progesterone |
| Activella | Other | Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally Receives: Drug: activella |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
Measured: 1 year
Secondary outcomes (2)
Comparison of the proportion of bleeding pattern between the two groups.
Measured: 1 year
To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010 (estimated)
- Study completionNov 2010 (estimated)
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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Investigators
- Boris Kaplan, prof, Principal investigator, Rabin Medical Center Beilinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919919
- Sponsor's protocol ID
- fr003
- Other IDs
- 5340/09
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Jennifer Blake. Menopause: evidence-based practice. Best Practice & Research Clinical Obstetrics and Gynaecology. 2006;20:799-839 2. Deborah Graby: Management of Menopausal Symptoms. The NEW ENGLAND JOURNAL of MEDICINE. 2006; 355:2338-47 3. Elena M. Treatment Strategies for Reducing the Burden of Menopause-Associated Vasomotor Symptoms. Journal of Managed Care Pharmacy. 2008;14(3):s14-s19 4. T.Levy. Z.Ben-Refael et al. Pharmacokinetics of natural progesterone administered in the form of a vaginal tablet. Human Reproduction. 1999;14(3):606-10 6. Devroey P, Palermo G, Bourgain C, et al. Progesterone administration in patients with absent ovaries. Int J Fertile. 1989;34:188- 93 7. Maxson WS, Hargrove JT. Bioavailability of oral micronized progesterone. Fertile Steril. 1985;44:622-26 8. C.Ficicioglu, B. Gurbuz, H. Canova. High local endometrial effect of vaginal progesterone gel. Gynecol Endocrinol. 2004;18:240-43 9. Steege JF, Rupp SL, Stout AL, et al. Bioavailability of nasally administered progesterone. Fertile Steril. 1986;46:722-29 10. Chakmakjian ZH, Zachariah NY. Bioavailability of progesterone with different modes of administration. J Reprod Med. 1987;32:443-48
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
- ClinicalTrials.gov ID
- NCT00919919
- Acronym / sponsor ID
- fr003
- Conditions
- Endometrial Hyperplasia, Endometrial Cancer
- Keywords
- menopause, Endometrial Thickness, progesterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 12 Jun 2009 (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 objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
Detailed description
Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone vaginal tablet | Experimental | Drug: progesteroneGroup A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally. |
| Activella | Other | Drug: activellaDaily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
- Women with an intact uterus.
- No menses within the 12 months preceding screening visit and /or FSH >30 IU/L.
- Endometrial thickness ≤ 5 mm.
Key exclusion criteria (2 listed)
- Submucosal fibroid/s that applying pressure and affecting endometrial thickness
- Other medication that could affect estrogenic state.
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 |
|---|---|---|
| progesteroneAlso: EndometrinDaily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month | Drug | Progesterone vaginal tablet |
| activellaDaily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally | Drug | Activella |
Primary outcome
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
Time frame: 1 year
2 secondary outcomes
Comparison of the proportion of bleeding pattern between the two groups.
Time frame: 1 year
To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
- Background1. Jennifer Blake. Menopause: evidence-based practice. Best Practice & Research Clinical Obstetrics and Gynaecology. 2006;20:799-839 2. Deborah Graby: Management of Menopausal Symptoms. The NEW ENGLAND JOURNAL of MEDICINE. 2006; 355:2338-47 3. Elena M. Treatment Strategies for Reducing the Burden of Menopause-Associated Vasomotor Symptoms. Journal of Managed Care Pharmacy. 2008;14(3):s14-s19 4. T.Levy. Z.Ben-Refael et al. Pharmacokinetics of natural progesterone administered in the form of a vaginal tablet. Human Reproduction. 1999;14(3):606-10 6. Devroey P, Palermo G, Bourgain C, et al. Progesterone administration in patients with absent ovaries. Int J Fertile. 1989;34:188- 93 7. Maxson WS, Hargrove JT. Bioavailability of oral micronized progesterone. Fertile Steril. 1985;44:622-26 8. C.Ficicioglu, B. Gurbuz, H. Canova. High local endometrial effect of vaginal progesterone gel. Gynecol Endocrinol. 2004;18:240-43 9. Steege JF, Rupp SL, Stout AL, et al. Bioavailability of nasally administered progesterone. Fertile Steril. 1986;46:722-29 10. Chakmakjian ZH, Zachariah NY. Bioavailability of progesterone with different modes of administration. J Reprod Med. 1987;32:443-48
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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.
Aviva Kaplan contact
Boris Kaplan, prof principal investigator
Rabin Medical Center Beilinson Hospital
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 progesterone and activella in people with Endometrial Hyperplasia and Endometrial Cancer, run by Rabin Medical Center at 1 site in Israel.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2009. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviva Kaplan (972-3-9377534), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. (time frame: 1 year). 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 NCT00919919, 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 12 Jun 2009.