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A post-marketing real-world observational study was carried out to investigate the safety and efficacy of 10 mg dydrogesterone in females having ovarian endometrioma.
Dydrogesterone decreases dysmenorrhea pain, prevents a rise in endometrioma size, improves total
dysmenorrhea scores and exhibits good tolerability in women with ovarian
endometrioma.
A post-marketing real-world observational study
was carried out to investigate the safety and efficacy of 10 mg dydrogesterone
in females having ovarian endometrioma.
In this open‐label multicenter study, the recruited participants were aged 20 to 49, with 47.4% cases aged ≥40 years. For four cycles, oral administration of dydrogesterone twice daily was given for 21 days (day 5-25 of every menstrual cycle).
The alteration in ovarian endometrioma volume from baseline
was the major endpoint. The secondary endpoints were (i) safety, (ii) severity
of dysmenorrhea pain symptoms [visual analog scale (VAS)], (iii) levels of
carbohydrate antigen 125 (CA-125) in serum, and (iv) total dysmenorrhea score
(0 = absent to 3 = severe).
The percentage of females in which endometrioma volume reduced, unchanged, and increased from baseline to the end of cycle 5 is shown in Table 1:
About three-quarters of participants thus had either declined or unchanged ovarian endometrioma volume. Dydrogesterone considerably minimized total dysmenorrhea scores and severity of dysmenorrhea pain VAS during therapy in comparison with the baseline, as illustrated in Figure 1:
The levels of CA-125 (a well-established marker for endometriosis) was slightly
dropped by dydrogesterone at the end of Cycle 5. However, the difference was
not statistically significant. The occurrence of
adverse drug reactions and adverse events in 59 subjects was 11.9% and 13.6%.
In women suffering
from ovarian endometriomas, 10 mg dydrogesterone remarkably improved total
dysmenorrhea scores (severity of symptoms + usage of rescue analgesics) and
severity of dysmenorrhea pain. Also, it displayed good tolerability.
Reproductive Medicine and Biology
An assessment of the efficacy and safety of dydrogesterone in women with ovarian endometrioma: An open-label multicenter clinical study
Jo Kitawaki et al.
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