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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2011

Interventions

  • Drug: NPC-01
    • NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
  • Drug: IKH-01
    • IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Arms, Groups and Cohorts

  • Experimental: NPC-01
    • 1mg norethisterone and 0.02mg ethinyl estradiol
  • Active Comparator: IKH-01
    • 1mg norethisterone and 0.35mg ethinyl estradiol

Clinical Trial Outcome Measures

Primary 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
    • 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
    • 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 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
    • 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
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nobelpharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Takefumi Matuo, MD, Principal Investigator, Hyogo Prefectural AWAJI Hospital

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