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NCT00689494 Clinical Trial

Cervical Device Contraception-2 (Nanopaz)

Healthy Clinical Trial

— NANOPAZ  

Official title:
Cervical Device Contraception

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00689494
Other study ID # BnaiZionMC-08-BP-003-CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received May 19, 2008
Last updated June 2, 2008
Start date June 2008
Est. completion date May 2010

Study information
Verified date June 2008
Source Bnai Zion Medical Center
Contact n/a
Is FDA regulated No
Health authority Macedonia: Ethics Committee
Study type Interventional

Clinical Trial Summary

Measure blood progesterone by using cervical device contraception.

Description:

A very small cervical device that releases small amount of progesterone 20 mcgm/day.

The target of the research is to measure blood progesterone by using the cervical device.

This small device delivers progesterone by nanotechnology method.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date May 2010
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 1 Month to 2 Months
Eligibility Inclusion Criteria:

- 10 healthy women are candidate for hysterectomy

Exclusion Criteria:

- Women with neoplastic malignancy disease or thrombophylia

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Nanopaz contraception device
levonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bnai Zion Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary blood progesterone measure in blood one to two months Yes
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