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Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00919919
Recruitment Status : Unknown
Verified June 2009 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 12, 2009
Last Update Posted : June 12, 2009
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by:
Rabin Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia Endometrial Cancer Drug: progesterone Drug: activella Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
Study Start Date : June 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Progesterone vaginal tablet
Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.
 Drug: progesterone
Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
Other Name: Endometrin
Activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
 Drug: activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally


Outcome Measures
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Primary Outcome Measures :
  1. Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Comparison of the proportion of bleeding pattern between the two groups. [ Time Frame: 1 year ]
  2. To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Submucosal fibroid/s that applying pressure and affecting endometrial thickness
  • Other medication that could affect estrogenic state.
Contacts and Locations
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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): NCT00919919


Contacts
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Contact: Aviva Kaplan 972-3-9377534

Locations
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Israel
Rabin Medical Center Beilinson Hospital
Petach Tikva, Israel
Contact: Aviva kaplan    972-50-5511591      
Principal Investigator: Boris kaplan, prof         
Sub-Investigator: Michael Hirsh, Dr'         
Sub-Investigator: Ravit Nahum, Dr'         
Sub-Investigator: Dove Lazarovitz, Dr'         
Sub-Investigator: Avi Ninio, Dr'         
Sub-Investigator: Yosi Maai, Dr'         
Sub-Investigator: Dan Kelman, Dr'         
Sub-Investigator: Raia Nir, Dr'         
Sub-Investigator: Ruth Bloch, Dr'         
Sub-Investigator: Yehuda Yeger, Dr'         
Sub-Investigator: Reuven Amster, Dr'         
Sub-Investigator: Tzvi Zehavi, Dr'         
Sub-Investigator: Gay Gutman, Dr'         
Sub-Investigator: Yosi Menkas, Dr'         
Sponsors and Collaborators
Rabin Medical Center
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Boris Kaplan, prof Rabin Medical Center Beilinson Hospital
More Information
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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

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Responsible Party: Prof. Boris Kaplan, Gynecology Department
ClinicalTrials.gov Identifier: NCT00919919    
Other Study ID Numbers: fr003
5340/09
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: June 2009
Keywords provided by Rabin Medical Center:
menopause
Endometrial Thickness
progesterone
Additional relevant MeSH terms:
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Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Diseases
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs