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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: IKH-01; Drug: NPC-01

• Registration Number: NCT01253824
• Lead Sponsor: Nobelpharma

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 available

Study Timeline

• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Study Start: 2011-01
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2014-04-10
• Results First Submitted QC: 2014-05-15
• Results First Posted: 2014-06-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IKH-01	IKH-01	1mg norethisterone and 0.35mg ethinyl estradiol
NPC-01	NPC-01	1mg norethisterone and 0.02mg ethinyl estradiol

Primary Outcome Measures

Name	Time	Method
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))	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))	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

Name	Time	Method
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))	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))	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