Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00919919 |
Recruitment Status : Unknown
Verified June 2009 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 12, 2009
Last Update Posted : June 12, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometrial Hyperplasia Endometrial Cancer | Drug: progesterone Drug: activella | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study |
Study Start Date : | June 2009 |
Estimated Primary Completion Date : | September 2010 |
Estimated Study Completion Date : | November 2010 |

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 Name: Endometrin |
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 |
- Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. [ Time Frame: 1 year ]
- Comparison of the proportion of bleeding pattern between the two groups. [ Time Frame: 1 year ]
- To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire. [ Time Frame: 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919919
Contact: Aviva Kaplan | 972-3-9377534 |
Israel | |
Rabin Medical Center Beilinson Hospital | |
Petach Tikva, Israel | |
Contact: Aviva kaplan 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' |
Principal Investigator: | Boris Kaplan, prof | Rabin Medical Center Beilinson Hospital |
Responsible Party: | Prof. Boris Kaplan, Gynecology Department |
ClinicalTrials.gov Identifier: | NCT00919919 |
Other Study ID Numbers: |
fr003 5340/09 |
First Posted: | June 12, 2009 Key Record Dates |
Last Update Posted: | June 12, 2009 |
Last Verified: | June 2009 |
menopause Endometrial Thickness progesterone |
Endometrial Neoplasms Endometrial Hyperplasia Hyperplasia Pathologic Processes Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Progesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |