Phase 3 N=14 Randomized Single-blind Treatment

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01253824 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: 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)) — 1654.7; 2478.0; 1872.6; 2434.9 pg･day/mL,

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: NPC-01 (Drug); IKH-01 (Drug)
Age: Adult · 20+ yrs
Sex: Female
Sponsor: Nobelpharma
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY 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))	1654.7; 2478.0; 1872.6; 2434.9	—
PRIMARY 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))	54.171; 93.148; 89.711; 59.344	—
SECONDARY 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))	-9.609; -4.380; -4.404; 0.538	—
SECONDARY 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))	60.874; 57.124; 61.571; 59.837	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01253824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.