NCT01253824

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 17, 2014

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

December 2, 2010

Results QC Date

April 10, 2014

Last Update Submit

February 18, 2025

Conditions

Healthy

Keywords

NPC-01IKH-01PharmacodynamicsNorethisteroneEthinyl EstradiolEstradiolProgesteroneFSHLH

Outcome Measures

Primary Outcomes (2)

  • 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 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))

    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))

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

Study Arms (2)

NPC-01

EXPERIMENTAL

1mg norethisterone and 0.02mg ethinyl estradiol

Drug: NPC-01

IKH-01

ACTIVE COMPARATOR

1mg norethisterone and 0.35mg ethinyl estradiol

Drug: IKH-01

Interventions

NPC-01DRUG

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

Also known as: norethisterone and ethinyl estradiol
NPC-01
IKH-01DRUG

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

Also known as: norethisterone and ethinyl estradiol
IKH-01

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Females who are pregnant
  • Drug use affecting sex hormone secretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

NorethindroneEthinyl Estradiol

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Department director of clinical development department 1
Organization
Nobelpharama
murakami@nobelpharma.co.jp
+81-23-5651-1177

Study Officials

  • Takefumi Matuo, MD

    Hyogo Prefectural AWAJI Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

March 6, 2025

Results First Posted

June 17, 2014

Record last verified: 2025-02