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Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT01253824
First received: December 2, 2010
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration cycle.


Condition Intervention Phase
Healthy Female
 Drug: NPC-01
Drug: IKH-01
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pharmacodynamics of NPC-01( 1mg Norethisterone and 0.02mg Ethinyl Estradiol) and IKH-01( 1mg Norethisterone and 0.035mg Ethinyl Estradiol); Effect of NPC-01 and IKH-01 on Serum Concentrations of Estradiol, Progesterone, FSH and LH.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Pharmacodynamics [ Time Frame: 3 menstrual cycles ] [ Designated as safety issue: No ]
    AUCt of estradiol and progesterone


Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: 3 menstrual cycles ] [ Designated as safety issue: No ]
    AUCt of FSH and LH, Mean changes of serum concentrations of estradiol, progesterone, FSH and LH


Enrollment: 14
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-01
1mg norethisterone and 0.02mg ethinyl estradiol
 Drug: NPC-01
NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
Other Name: norethisterone and ethinyl estradiol
Active Comparator: IKH-01
1mg norethisterone and 0.35mg ethinyl estradiol
 Drug: IKH-01
IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
Other Name: norethisterone and ethinyl estradiol

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female aged between 20 to 35 years
  • BMI:18.0-26.0

Exclusion Criteria:

  • Females who are pregnant
  • Drug use affecting sex hormone secretion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253824

Sponsors and Collaborators
Nobelpharma
Investigators
Principal Investigator: Takefumi Matuo, MD Hyogo Prefectural AWAJI Hospital
  More Information

No publications provided

Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT01253824     History of Changes
Other Study ID Numbers: NPC-01-4
Study First Received: December 2, 2010
Last Updated: October 16, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nobelpharma:
NPC-01
IKH-01
Pharmacodynamics
Norethisterone
Ethinyl Estradiol
 Estradiol
Progesterone
FSH
LH

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins

ClinicalTrials.gov processed this record on May 23, 2013