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Cervical Device Contraception-2 (Nanopaz) (NANOPAZ)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Bnai Zion Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689494
First Posted: June 3, 2008
Last Update Posted: June 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bnai Zion Medical Center
  Purpose
Measure blood progesterone by using cervical device contraception.

Condition Intervention Phase
Healthy Other: Nanopaz contraception device Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cervical Device Contraception

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • blood progesterone measure in blood [ Time Frame: one to two months ]

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
    Other Name: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 2 Months   (Child)
Sexes 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: Baram Paz, Bnai Zion MC
ClinicalTrials.gov Identifier: NCT00689494     History of Changes
Other Study ID Numbers: BnaiZionMC-08-BP-003-CTIL
First Submitted: May 19, 2008
First Posted: June 3, 2008
Last Update Posted: June 3, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
Progesterone
Levonorgestrel
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral