PMID- 34927507
OWN - NLM
STAT- MEDLINE
DCOM- 20220401
LR  - 20220429
IS  - 1473-0766 (Electronic)
IS  - 0951-3590 (Linking)
VI  - 38
IP  - 4
DP  - 2022 Apr
TI  - Dydrogesterone after 60 years: a glance at the safety profile.
PG  - 279-287
LID - 10.1080/09513590.2021.2016692 [doi]
AB  - OBJECTIVE: To provide an evidence-based safety and tolerability overview of 
      dydrogesterone under various progesterone-deficient conditions as a commemoration 
      of its role in managing women's reproductive health over the past 60 years. 
      METHODS: To identify relevant publications, we used a semi-systematic approach, 
      which included performing a structured search through the PubMed and Cochrane 
      central databases as well as an unstructured search for publications published in 
      English from 2010 onward with human clinical data. RESULTS: A total of 32 
      relevant clinical studies were identified. Results were reported in the context 
      of overall adverse events (AEs) and segregated according to various 
      progesterone-deficient conditions. AEs concerning breasts (breast cancer risk), 
      the endometrium (endometrial cancer risk), venous thromboembolism risk, and 
      cardiovascular risk were found to be minimal when dydrogesterone was used as part 
      of a menopausal hormone therapy regimen lasting </=260 weeks. Vagina-related AEs, 
      such as bleeding, discharge, irritation, and difficult coitus, occurred less 
      frequently with dydrogesterone when used as luteal phase support in the context 
      of assisted reproductive techniques (ARTs). However, other common AEs, such as 
      headache, dizziness, abdominal pain, flatulence, and nausea, occurred more 
      frequently with dydrogesterone. No maternal complications or congenital anomalies 
      could be linked to dydrogesterone usage during ARTs or during early pregnancy to 
      prevent recurrent miscarriages. Studies on dydrogesterone in endometriosis and 
      premenstrual syndrome remain scarce. CONCLUSIONS: Post-approval, dydrogesterone 
      has displayed a favorable safety and tolerability profile during its 60-year use, 
      which is reassuring, considering its important role in managing women's 
      reproductive health.
FAU - Ott, Johannes
AU  - Ott J
AD  - Clinical Division of Gynecologic Endocrinology and Reproductive Medicine, Medical 
      University of Vienna, Vienna, Austria.
FAU - Egarter, Christian
AU  - Egarter C
AD  - Clinical Division of Gynecologic Endocrinology and Reproductive Medicine, Medical 
      University of Vienna, Vienna, Austria.
FAU - Aguilera, Alex
AU  - Aguilera A
AD  - Global Key Brands, Women's Health, Barcelona, Spain.
LA  - eng
PT  - Journal Article
DEP - 20211220
PL  - England
TA  - Gynecol Endocrinol
JT  - Gynecological endocrinology : the official journal of the International Society 
      of Gynecological Endocrinology
JID - 8807913
RN  - 4G7DS2Q64Y (Progesterone)
RN  - 90I02KLE8K (Dydrogesterone)
SB  - IM
MH  - *Dydrogesterone/adverse effects
MH  - Female
MH  - Humans
MH  - *Luteal Phase
MH  - Pregnancy
MH  - Pregnancy Rate
MH  - Progesterone/therapeutic use
MH  - Reproductive Techniques, Assisted
OTO - NOTNLM
OT  - Assisted reproductive technology
OT  - cycle regularization
OT  - dydrogesterone
OT  - endometriosis
OT  - habitual abortion
OT  - luteal phase support
OT  - menopausal hormone therapy
OT  - menstrual bleeding
EDAT- 2021/12/21 06:00
MHDA- 2022/04/02 06:00
CRDT- 2021/12/20 08:44
PHST- 2021/12/21 06:00 [pubmed]
PHST- 2022/04/02 06:00 [medline]
PHST- 2021/12/20 08:44 [entrez]
AID - 10.1080/09513590.2021.2016692 [doi]
PST - ppublish
SO  - Gynecol Endocrinol. 2022 Apr;38(4):279-287. doi: 10.1080/09513590.2021.2016692. 
      Epub 2021 Dec 20.