Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

Endometrial Hyperplasia Clinical Trial

Official title:

Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00123175
• Other study ID #: 21012
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: July 20, 2005
• Last updated: January 7, 2013
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.

Description:

Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic diagnosis of simple or complex endometrial hyperplasia without atypia

• Normal pap smear within one year

Exclusion Criteria:

• Diabetes

• Family history of endometrial cancer

• Contraindications for the intrauterine device

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia

Intervention

Device:
• Intrauterine Device
Mirena and Provera

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Center for Research on Women and Newborn Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera		90 days	No
Secondary	Side effects		90 days	No
Secondary	Bleeding profile		90 days	No
Secondary	Estradiol and progesterone levels		90 days	No