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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: NPC-01; Drug: IKH-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253824

NPC-01-4

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

NPC-01

Experimental group

Description:

1mg norethisterone and 0.02mg ethinyl estradiol

Treatment:

Drug: NPC-01

IKH-01

Active Comparator group

Description:

1mg norethisterone and 0.35mg ethinyl estradiol

Treatment:

Drug: IKH-01