MedDataX Logo

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

NCT ID: NCT01253824

Last Updated: 2025-03-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers

NCT01246791

Healthy
COMPLETED PHASE3

A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects

NCT03662516

Healthy Females
COMPLETED PHASE1

Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea

NCT00746096

Dysmenorrhea
COMPLETED PHASE3

Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids

NCT04018274

Healthy
COMPLETED PHASE1

Study of Safety and Efficacy of an Oral Contraceptive

NCT00477633

Contraception
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NPC-01

1mg norethisterone and 0.02mg ethinyl estradiol

Group Type EXPERIMENTAL

NPC-01

Intervention Type DRUG

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

IKH-01

1mg norethisterone and 0.35mg ethinyl estradiol

Group Type ACTIVE_COMPARATOR

IKH-01

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NPC-01

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

Intervention Type DRUG

IKH-01

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

norethisterone and ethinyl estradiol norethisterone and ethinyl estradiol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nobelpharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Takefumi Matuo, MD

Role: PRINCIPAL_INVESTIGATOR

Hyogo Prefectural AWAJI Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NPC-01-4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Feasibility Study Into the Contraceptive Effect of Estetrol
NCT00563472 COMPLETED PHASE2
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
NCT02175394 COMPLETED PHASE1
The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
NCT00254800 COMPLETED PHASE1
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
NCT05064332 COMPLETED PHASE1
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
NCT03608241 COMPLETED PHASE1
Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
NCT02170038 COMPLETED PHASE1
A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children.
NCT06188026 COMPLETED PHASE1
A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)
NCT01166412 COMPLETED PHASE1/PHASE2
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
NCT05294341 COMPLETED PHASE4
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
NCT00004763 COMPLETED PHASE2
Investigation of Female Reproductive Hormone Dynamics During Adolescence
NCT02486757 COMPLETED EARLY_PHASE1
A Study of Efficacy and Safety With the Transdermal Contraceptive System.
NCT00236769 COMPLETED PHASE3
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
NCT00212342 COMPLETED PHASE3
Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
NCT00212277 COMPLETED PHASE3
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
NCT04267250 COMPLETED PHASE1
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
NCT00196326 COMPLETED PHASE3
A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant
NCT06461039 COMPLETED PHASE1
Assessing the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of Combined Oral Contraceptives in Healthy Female Participants of Non-childbearing Potential.
NCT05505162 COMPLETED PHASE1
A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone
NCT02652650 COMPLETED PHASE1
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
NCT00033358 COMPLETED PHASE2
Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)
NCT01650168 COMPLETED
A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women
NCT01586000 COMPLETED PHASE2
A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Women
NCT00915668 WITHDRAWN PHASE1
Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle
NCT00204438 COMPLETED NA
A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive
NCT03506399 WITHDRAWN PHASE1