HealthyPhase 3NCT01253824

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

A Phase 3 study testing NPC-01 and IKH-01 in people with Healthy, run by Nobelpharma.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: NPC-01 and IKH-01
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: No sites listed yet
Study dates: Jan 2011to Jul 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female aged between 20 to 35 years
BMI:18.0-26.0

Who cannot join

Females who are pregnant
Drug use affecting sex hormone secretion

About this study

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.

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.

Conditions: Healthy
Being tested: NPC-01, IKH-01
Keywords: NPC-01, IKH-01, Pharmacodynamics, Norethisterone, Ethinyl Estradiol, Estradiol, Progesterone, FSH, LH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NPC-01Drug
Also called norethisterone and ethinyl estradiol
NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
IKH-01Drug
Also called norethisterone and ethinyl estradiol
IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Study groups in NCT01253824
Study group	Role	What they receive
NPC-01	Experimental	1mg norethisterone and 0.02mg ethinyl estradiol Receives: Drug: NPC-01
IKH-01	Active comparator	1mg norethisterone and 0.35mg ethinyl estradiol Receives: Drug: IKH-01

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jul 2011

First posted3 Dec 2010 (estimated)
Study startJan 2011
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01253824
Sponsor's protocol ID: NPC-01-4
Status last verified: Feb 2025
First submitted: 2 Dec 2010
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01253824
Acronym / sponsor ID: NPC-01-4
Conditions: Healthy
Keywords: NPC-01, IKH-01, Pharmacodynamics, Norethisterone, Ethinyl Estradiol, Estradiol, Progesterone, FSH
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: NobelpharmaIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 17 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
NPC-01	Experimental	Drug: NPC-011mg norethisterone and 0.02mg ethinyl estradiol
IKH-01	Active comparator	Drug: IKH-011mg norethisterone and 0.35mg ethinyl estradiol

Who may qualify

Ages: 20 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy female aged between 20 to 35 years
BMI:18.0-26.0

Key exclusion criteria (2 listed)

Females who are pregnant
Drug use affecting sex hormone secretion

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NPC-01Also: norethisterone and ethinyl estradiolNPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol	Drug	NPC-01
IKH-01Also: norethisterone and ethinyl estradiolIKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol	Drug	IKH-01

Primary outcome

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
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

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 17 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NPC-01	7	7
IKH-01	7	7

Primary outcome: 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. Mean (Standard Deviation). Unit: pg･day/mL,

Measure	NPC-01 n = 7	IKH-01 n = 7
Difference of estradiol AUC (BL-SDA)	1654.7 (1652.6)	2478.0 (793.0)
Difference of estradiol AUC(FU-SDA)	1872.6 (1819.2)	2434.9 (1151.5)

Primary outcome: 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. Mean (Standard Deviation). Unit: ng･day/mL

Measure	NPC-01 n = 7	IKH-01 n = 7
Difference of progesterone(BL-SDA)	54.171 (25.769)	93.148 (45.867)
Difference of progesterone(FU-SDA)	89.711 (47.882)	59.344 (49.160)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NPC-01	0 of 7 (0%)	6 of 7 (85.7%)	Not reported
IKH-01	0 of 7 (0%)	6 of 7 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takefumi Matuo, MD principal investigator

Hyogo Prefectural AWAJI Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NPC-01 and IKH-01 in people with Healthy, run by Nobelpharma.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01253824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.