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

Information source: Nobelpharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: NPC-01 (Drug); IKH-01 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Nobelpharma

Official(s) and/or principal investigator(s):
Takefumi Matuo, MD, Principal Investigator, Affiliation: Hyogo Prefectural AWAJI Hospital

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

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))

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))

Secondary outcome:

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))

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))

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: January 2011
Last updated: May 15, 2014

Page last updated: August 23, 2015

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