NCT00919919

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

June 9, 2009

Last Update Submit

June 11, 2009

Conditions

Endometrial HyperplasiaEndometrial Cancer

Keywords

menopauseEndometrial Thicknessprogesterone

Outcome Measures

Primary Outcomes (1)

  • Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.

    1 year

Secondary Outcomes (2)

  • Comparison of the proportion of bleeding pattern between the two groups.

    1 year

  • To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.

    1 year

Study Arms (2)

Progesterone vaginal tablet

EXPERIMENTAL

Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.

Drug: progesterone

Activella

OTHER

Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Drug: activella

Interventions

progesteroneDRUG

Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month

Also known as: Endometrin
Progesterone vaginal tablet
activellaDRUG

Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Activella

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Submucosal fibroid/s that applying pressure and affecting endometrial thickness
  • Other medication that could affect estrogenic state.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center Beilinson Hospital

Petah Tikva, Israel

Location

Related 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

    BACKGROUND

MeSH Terms

Conditions

Endometrial HyperplasiaEndometrial Neoplasms

Interventions

Progesteroneestradiol, norethindrone drug combination

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Boris Kaplan, prof

    Rabin Medical Center Beilinson Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aviva Kaplan

CONTACT

972-3-9377534

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 12, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

IL(1)