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

June 11, 2009 updated by: Rabin Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aviva Kaplan
  • Phone Number: 972-3-9377534

Study Locations

  • Israel
      • Petach Tikva, Israel
        • Rabin Medical Center Beilinson Hospital
        • Contact:
          • Aviva kaplan
          • Phone Number: 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'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Endometrin
OTHER: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Boris Kaplan, prof, Rabin Medical Center Beilinson Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

September 1, 2010

Study Completion (ANTICIPATED)

November 1, 2010

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (ESTIMATE)

June 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2009

Last Update Submitted That Met QC Criteria

June 11, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fr003
  • 5340/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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