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

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ClinicalTrials.gov Identifier: NCT01253824
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

Tracking Information
First Submitted Date  ICMJE December 2, 2010
First Posted Date  ICMJE December 3, 2010
Results First Submitted Date  ICMJE April 10, 2014
Results First Posted Date  ICMJE June 17, 2014
Last Update Posted Date June 17, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
Pharmacodynamics [ Time Frame: 3 menstrual cycles ]
AUCt of estradiol and progesterone
Change History Complete list of historical versions of study NCT01253824 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
Pharmacodynamics [ Time Frame: 3 menstrual cycles ]
AUCt of FSH and LH, Mean changes of serum concentrations of estradiol, progesterone, FSH and LH
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: NPC-01
    NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
    Other Name: norethisterone and ethinyl estradiol
  • Drug: IKH-01
    IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
    Other Name: norethisterone and ethinyl estradiol
Study Arms  ICMJE
  • Experimental: NPC-01
    1mg norethisterone and 0.02mg ethinyl estradiol
    Intervention: Drug: NPC-01
  • Active Comparator: IKH-01
    1mg norethisterone and 0.35mg ethinyl estradiol
    Intervention: Drug: IKH-01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2012)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2010)
16
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01253824
Other Study ID Numbers  ICMJE NPC-01-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nobelpharma
Study Sponsor  ICMJE Nobelpharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Takefumi Matuo, MD Hyogo Prefectural AWAJI Hospital
PRS Account Nobelpharma
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP