Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers
Overview
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.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: July 2011
Interventions
- Drug: NPC-01
- NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
- Drug: IKH-01
- IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
Arms, Groups and Cohorts
- Experimental: NPC-01
- 1mg norethisterone and 0.02mg ethinyl estradiol
- Active Comparator: IKH-01
- 1mg norethisterone and 0.35mg ethinyl estradiol
Clinical Trial Outcome Measures
Primary Measures
- 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))
- Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
- 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
- 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))
- Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
- 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
Secondary Measures
- 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))
- Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
- FSH 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
- 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))
- Time Frame: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
- LH 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
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 20 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Nobelpharma
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Takefumi Matuo, MD, Principal Investigator, Hyogo Prefectural AWAJI Hospital
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