Clinical trial NCT00919919: Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
Official title: Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometrial Hyperplasia
Endometrial Cancer
Keywords: menopause
Endometrial Thickness
progesterone
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2009-06-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of the proportion of bleeding pattern between the two groups.
timeFrame: 1 year
measure: To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.
timeFrame: 1 year
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center Beilinson Hospital
name: Boris Kaplan, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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