Clinical trial · Interventional
Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
NCT00919919CI-TRIAL-00002374unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Hyperplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| activella | Drug | — | UNRESOLVED |
| progesterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Progesterone vaginal tablet
- description
- Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.
- interventionNames
- Drug: progesterone
- type
- OTHER
- label
- Activella
- description
- Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
- interventionNames
- Drug: activella
Primary outcomes (1)
- measure
- Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUND1. 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