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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: NPC-01
* Drug: IKH-01


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-01<br>1mg norethisterone and 0.02mg ethinyl estradiol | Drug: NPC-01<br>* NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol<br>* Other names: norethisterone and ethinyl estradiol;|
| Active Comparator: IKH-01<br>1mg norethisterone and 0.35mg ethinyl estradiol | Drug: IKH-01<br>* IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol<br>* Other names: norethisterone and ethinyl estradiol;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LH, NPC-01, IKH-01, Pharmacodynamics, Norethisterone, Ethinyl Estradiol, Estradiol, Progesterone, FSH