Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II

NCT00247169 | Completed Phase 2

• 1 other identifier: UFK-HEF 4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

cervical intraepithelial neoplasia (CIN); progesterone

Outcome Measures

Primary Outcomes (1)

• To evaluate whether or not a treatment with vaginal progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months increases regression rates of CIN I and II.

  6 months

Secondary Outcomes (1)

• Change of immunohistochemically detected expression of Langerhans Cells in CIN

  6 months

Interventions

progesterone DRUG

Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Histological evidence of CIN I and II
• Transformation zone and lesion margins fully visible
• Compliant subject
• Safe contraception
• Negative pregnancy test

You may not qualify if:

• Lesion related
• CIN III, (micro)-Invasive Cancer
• Endocervical lesion, upper margin of lesion not visible on colposcopy
• Non-compliance of patient
• PAP V
• Drug related
• Age \> 60
• Hypersensitivity to progesterone or any component of the formulation
• Thrombophlebitis
• Undiagnosed vaginal bleeding
• Carcinoma of the breast
• Cerebral apoplexy
• Severe liver dysfunction
• Pregnancy
• Depression

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Dept OB/GYN, Med University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Lukas A Hefler, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 1, 2005
• Study Start: August 1, 2004
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

AU (1)