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: May 15, 2014
Last verified: May 2014
  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
Drug: NPC-01
Drug: IKH-01
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel 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:


Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) [ Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles ] [ Designated as safety issue: No ]
    Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data

  • Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) [ Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles ] [ Designated as safety issue: No ]
    Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data


Secondary Outcome Measures:
  • Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) [ Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles ] [ Designated as safety issue: No ]
    FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data

  • Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) [ Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles ] [ Designated as safety issue: No ]
    LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 10, 2014
Last Updated: May 15, 2014
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
Mestranol
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Norethindrone
Norethindrone acetate
Norinyl
Ethynylestradiol mixture with norethindrone
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
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential

ClinicalTrials.gov processed this record on September 18, 2014