CompletedPhase 3

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

14 participantsStarted 2011-01

Plain-language 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.

Who can participate

Age range20 Years – 35 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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))

Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

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))

Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles

Trial details

NCT IDNCT01253824

SponsorNobelpharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07

Results submitted2014-04-10

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