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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00919919
Other study ID # fr003
Secondary ID 5340/09
Status Not yet recruiting
Phase Phase 2
First received June 9, 2009
Last updated June 11, 2009
Start date June 2009
Est. completion date November 2010

Study information

Verified date June 2009
Source Rabin Medical Center
Contact Aviva Kaplan
Phone 972-3-9377534
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
progesterone
Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Locations

Country Name City State
Israel Rabin Medical Center Beilinson Hospital Petach Tikva

Sponsors (2)

Lead Sponsor Collaborator
Rabin Medical Center Ferring Pharmaceuticals

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. 1 year Yes
Secondary Comparison of the proportion of bleeding pattern between the two groups. 1 year Yes
Secondary To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire. 1 year Yes
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