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

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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

Tracking Information
First Submitted Date  ICMJE June 9, 2009
First Posted Date  ICMJE June 12, 2009
Last Update Posted Date June 12, 2009
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
Official Title  ICMJE Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Hyperplasia
  • Endometrial Cancer
Intervention  ICMJE
  • Drug: progesterone
    Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
    Other Name: Endometrin
  • Drug: activella
    Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
Study Arms  ICMJE
  • Experimental: Progesterone vaginal tablet
    Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.
    Intervention: Drug: progesterone
  • Activella
    Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
    Intervention: Drug: activella
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2010
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919919
Other Study ID Numbers  ICMJE fr003
5340/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Boris Kaplan, Gynecology Department
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Ferring Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Boris Kaplan, prof Rabin Medical Center Beilinson Hospital
PRS Account Rabin Medical Center
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP