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
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