PMID- 38262424
OWN - NLM
STAT- MEDLINE
DCOM- 20240404
LR  - 20240404
IS  - 1447-0756 (Electronic)
IS  - 1341-8076 (Linking)
VI  - 50
IP  - 4
DP  - 2024 Apr
TI  - A phase I/II study evaluating the pharmacokinetics, pharmacodynamics, and safety 
      of drospirenone as an oral contraceptive in Japanese women.
PG  - 682-690
LID - 10.1111/jog.15881 [doi]
AB  - AIM: Drospirenone (DRSP) is a synthetic progestogen approved as a progestin-only 
      pill for contraception in both the United States and Europe. Herein, we conducted 
      a phase I/II study to evaluate the pharmacokinetics, pharmacodynamics, and safety 
      of DRSP in Japanese women. METHODS: Single and multiple doses of 4 mg of DRSP 
      were orally administered to healthy premenopausal Japanese women. In the 
      multiple-dose period, 4 mg of DRSP was administered once daily for 24 days. 
      Pharmacokinetics, hormone levels, and adverse events (AEs) were investigated. 
      RESULTS: Twelve Japanese women participated in this study. The single- and 
      multiple-dose pharmacokinetics of DRSP was similar to that reported in previous 
      studies in Caucasians. In the multiple-dose period, no subject displayed a 
      progesterone level of more than 5.03 ng/mL. AEs were observed in 11 (91.7%) 
      subjects. The most common AE was genital hemorrhage, which was observed in six 
      (50.0%) subjects, followed by diarrhea and acne in four (33.3%) subjects each. 
      All AEs resolved or improved at the end of the study, and complete recovery was 
      confirmed in all subjects at follow-up. CONCLUSIONS: The pharmacokinetics of DRSP 
      in Japanese women was similar to that of previous studies performed in Caucasian 
      women. Repeated administration of DRSP maintained low plasma progesterone levels 
      indicating effective inhibition of ovulation. No notable safety concerns were 
      observed. In this phase I/II study, DRSP had no obvious pharmacokinetic, 
      pharmacodynamic, or safety issues to consider in Japanese women.
CI  - (c) 2024 Exeltis. ASKA Pharmaceutical Co., Ltd and The Authors. Journal of 
      Obstetrics and Gynaecology Research published by John Wiley & Sons Australia, Ltd 
      on behalf of Japan Society of Obstetrics and Gynecology.
FAU - Kitamura, Kunio
AU  - Kitamura K
AD  - Japan Family Planning Association, Tokyo, Japan.
FAU - Colli, Enrico
AU  - Colli E
AUID- ORCID: 0009-0008-9137-0950
AD  - Research and Development Department, Exeltis, Madrid, Spain.
FAU - Azuma, Rieko
AU  - Azuma R
AUID- ORCID: 0009-0006-2406-1985
AD  - Development Division, ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.
FAU - Kikuyama, Ryoko
AU  - Kikuyama R
AUID- ORCID: 0009-0008-8043-236X
AD  - Development Division, ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.
FAU - Kanai, Masayuki
AU  - Kanai M
AUID- ORCID: 0009-0007-7924-2780
AD  - Development Division, ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.
LA  - eng
GR  - ASKA Pharmaceutical Co., Ltd./
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20240123
PL  - Australia
TA  - J Obstet Gynaecol Res
JT  - The journal of obstetrics and gynaecology research
JID - 9612761
RN  - 0 (Contraceptives, Oral)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - N295J34A25 (drospirenone)
RN  - 4G7DS2Q64Y (Progesterone)
RN  - 0 (Androstenes)
SB  - IM
MH  - Female
MH  - Humans
MH  - *Contraceptives, Oral
MH  - *Ethinyl Estradiol/adverse effects
MH  - Japan
MH  - Progesterone
MH  - Contraception
MH  - *Androstenes
OTO - NOTNLM
OT  - drospirenone
OT  - oral contraceptives
OT  - pharmacodynamics
OT  - pharmacokinetics
OT  - progesterone-only pill
EDAT- 2024/01/24 00:42
MHDA- 2024/04/04 06:45
CRDT- 2024/01/23 18:43
PHST- 2023/09/18 00:00 [received]
PHST- 2023/12/28 00:00 [accepted]
PHST- 2024/04/04 06:45 [medline]
PHST- 2024/01/24 00:42 [pubmed]
PHST- 2024/01/23 18:43 [entrez]
AID - 10.1111/jog.15881 [doi]
PST - ppublish
SO  - J Obstet Gynaecol Res. 2024 Apr;50(4):682-690. doi: 10.1111/jog.15881. Epub 2024 
      Jan 23.