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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Ferring Pharmaceuticals
Information provided by:
Rabin Medical Center Identifier:
First received: June 9, 2009
Last updated: June 11, 2009
Last verified: June 2009
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 Intervention Phase
Endometrial Hyperplasia
Endometrial Cancer
Drug: progesterone
Drug: activella
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00919919

Contact: Aviva Kaplan 972-3-9377534

Rabin Medical Center Beilinson Hospital Not yet recruiting
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
Principal Investigator: Boris Kaplan, prof Rabin Medical Center Beilinson Hospital
  More Information

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

Responsible Party: Prof. Boris Kaplan, Gynecology Department Identifier: NCT00919919     History of Changes
Other Study ID Numbers: fr003
Study First Received: June 9, 2009
Last Updated: June 11, 2009

Keywords provided by Rabin Medical Center:
Endometrial Thickness

Additional relevant MeSH terms:
Endometrial Neoplasms
Endometrial Hyperplasia
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Norethindrone acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents processed this record on May 22, 2017