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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: NPC-01 Drug: IKH-01 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : January 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253824


Sponsors and Collaborators
Nobelpharma
Investigators
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Principal Investigator: Takefumi Matuo, MD Hyogo Prefectural AWAJI Hospital
More Information
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Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT01253824    
Other Study ID Numbers: NPC-01-4
First Posted: December 3, 2010    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014
Keywords provided by Nobelpharma:
NPC-01
IKH-01
Pharmacodynamics
Norethisterone
Ethinyl Estradiol
 Estradiol
Progesterone
FSH
LH
Additional relevant MeSH terms:
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Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Norinyl
Mestranol
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined