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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01253824
Enrollment
14
Registered
2010-12-03
Start date
2011-01-31
Completion date
2011-07-31
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

NPC-01, IKH-01, Pharmacodynamics, Norethisterone, Ethinyl Estradiol, Estradiol, Progesterone, FSH, 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.

Interventions

DRUGNPC-01

NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol

DRUGIKH-01

IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Sponsors

Nobelpharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 cyclesEstradiol 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 cyclesProgesterone 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

MeasureTime frameDescription
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 cyclesFSH 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 cyclesLH 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

Participant flow

Recruitment details

Fifty one subjects were screened for this study after acquiring an informed consent. 18 subjects of those participated in pre-medication menstrual cycle phase to confirm baseline of estradiol, progesterone, FSH and LH. 4 subjects withdrew IC during this phase, therefore, 14 subjects were registered and allocated study drugs.

Participants by arm

ArmCount
NPC-01
1mg norethisterone and 0.02mg ethinyl estradiol NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
7
IKH-01
1mg norethisterone and 0.35mg ethinyl estradiol IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
7
Total14

Baseline characteristics

CharacteristicNPC-01IKH-01Total
Age, Continuous26.6 years
STANDARD_DEVIATION 2.3
26.1 years
STANDARD_DEVIATION 4.4
26.4 years
STANDARD_DEVIATION 3.4
Body weight51.14 kg
STANDARD_DEVIATION 4.23
51.86 kg
STANDARD_DEVIATION 6.03
51.5 kg
STANDARD_DEVIATION 5.01
Sex/Gender, Customized
Female
7 participants7 participants14 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
6 / 76 / 7
serious
Total, serious adverse events
0 / 70 / 7

Outcome results

Primary

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

Time frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

ArmMeasureGroupValue (MEAN)Dispersion
NPC-01Comparing 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))Difference of estradiol AUC (BL-SDA)1654.7 pg･day/mL,Standard Deviation 1652.6
NPC-01Comparing 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))Difference of estradiol AUC(FU-SDA)1872.6 pg･day/mL,Standard Deviation 1819.2
IKH-01Comparing 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))Difference of estradiol AUC (BL-SDA)2478.0 pg･day/mL,Standard Deviation 793
IKH-01Comparing 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))Difference of estradiol AUC(FU-SDA)2434.9 pg･day/mL,Standard Deviation 1151.5
Primary

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

Time frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

ArmMeasureGroupValue (MEAN)Dispersion
NPC-01Comparing 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))Difference of progesterone(BL-SDA)54.171 ng･day/mLStandard Deviation 25.769
NPC-01Comparing 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))Difference of progesterone(FU-SDA)89.711 ng･day/mLStandard Deviation 47.882
IKH-01Comparing 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))Difference of progesterone(BL-SDA)93.148 ng･day/mLStandard Deviation 45.867
IKH-01Comparing 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))Difference of progesterone(FU-SDA)59.344 ng･day/mLStandard Deviation 49.16
Secondary

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

Time frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

ArmMeasureGroupValue (MEAN)Dispersion
NPC-01Comparing 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))Differnce of FSH (BL-SDA)-9.609 mIU･day/mLStandard Deviation 20.879
NPC-01Comparing 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))Difference of FSH(FP-SDA)-4.404 mIU･day/mLStandard Deviation 41.309
IKH-01Comparing 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))Differnce of FSH (BL-SDA)-4.380 mIU･day/mLStandard Deviation 18.034
IKH-01Comparing 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))Difference of FSH(FP-SDA)0.538 mIU･day/mLStandard Deviation 30.497
Secondary

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

Time frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

ArmMeasureGroupValue (MEAN)Dispersion
NPC-01Comparing 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))Difference of LH(BL-SDA)60.874 mIU･day/mLStandard Deviation 41.2
NPC-01Comparing 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))Difference of LH(FU-SDA)61.571 mIU･day/mLStandard Deviation 89.546
IKH-01Comparing 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))Difference of LH(BL-SDA)57.124 mIU･day/mLStandard Deviation 50.821
IKH-01Comparing 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))Difference of LH(FU-SDA)59.837 mIU･day/mLStandard Deviation 25.549

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026