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

Endometrial Cancer Clinical Trial

Official title:

Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study

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

• Endometrial Cancer
• Endometrial Hyperplasia
• Hyperplasia

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