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Cervical Device Contraception-2 (Nanopaz) (NANOPAZ)
This study is not yet open for participant recruitment.
Verified by Bnai Zion Medical Center, June 2008
Sponsored by: Bnai Zion Medical Center
Information provided by: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT00689494
  Purpose

Measure blood progesterone by using cervical device contraception.


Condition Intervention Phase
Healthy
 Other: Nanopaz contraception device
 Phase I
Phase II

MedlinePlus related topics: Birth Control
Drug Information available for: Progesterone Levonorgestrel
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Cervical Device Contraception

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • blood progesterone measure in blood [ Time Frame: one to two months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • no [ Time Frame: no ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Nanopaz contraception device
    levonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method
Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Month to 2 Months
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 10 healthy women are candidate for hysterectomy

Exclusion Criteria:

  • Women with neoplastic malignancy disease or thrombophylia
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Bnai Zion MC ( Baram Paz )
Study ID Numbers: BnaiZionMC-08-BP-003-CTIL
Study First Received: May 19, 2008
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00689494  
Health Authority: Macedonia: Ethics Committee

Keywords provided by Bnai Zion Medical Center:
Nanopaz device
Blood progesterone measure in using the device
Delivery progesterone
Progesterone levonorgestrel

Study placed in the following topic categories:
Progesterone
Levonorgestrel
Healthy

Additional relevant MeSH terms:
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
 Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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