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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NPC-01; Drug: IKH-01

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: norethisterone and ethinyl estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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))	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	Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
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))	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	Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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))	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	Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
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))	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	Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

Collaborators and Investigators

• Sponsor: Nobelpharma
• Investigators: Principal Investigator: Takefumi Matuo, MD, Hyogo Prefectural Awaji Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacodynamics; Progesterone; Estradiol; FSH; LH; NPC-01; Norethisterone; Ethinyl Estradiol; IKH-01
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Estradiol; Ethinyl Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Norethindrone; Norethindrone Acetate; Norinyl; Mestranol
• Other Study ID Numbers: NPC-01-4