Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding – ovulation dysfunction patients

Table 1 Baseline and demographics of the study population (full analysis set)

Variables	n (missing)	Values, mean ± SD; n (%)
Age (yr)	114 (0)	24.5 ± 6.3
Average days of menstrual cycles in the	96 (18)	63.7 ± 25.5
Last three months
Average days of menstrual periods in the	108 (6)	7.1 ± 6.2
Last three months
Urine pregnancy test (enrollment)	114 (0)
Negative		1 (0.9)
Positive		0 (0.0)
Not applicable		5 (4.4)
Deferred		108 (94.7)
Diagnosis of polycystic ovaries syndrome 114 (0)
Yes		41 (36.0)
No		73 (64.0)

Table 2 Percentage of patients who achieved regular menstrual cycles after dydrogesterone treatment

Variables	FAS analysis			PPS analysis
	n (missing)1	Normal	Rate (95%CI)	n (missing)1	Normal	Rate (95%CI)
Percentage of patients who achieved regular MC after	89 (18)	72	80.9 (71.2-88.5)	65 (10)	62	95.4 (87.1-99.0)
Three cycles of dydrogesterone treatment
Subgroups
Patients with menstrual cycle > 35 d	63 (25)	61	96.8 (89.0-99.6)	63 (1)	61	96.8 (89.0-99.6)
Patients with menstrual period > 8 d	8 (3)	7	87.5 (47.3-99.7)	8 (0)	7	87.5 (47.3-99.7)
After cycle 1 treatment of dydrogesterone	75 (32)	71	94.7 (86.9-98.5)	64 (11)	61	95.3 (86.9-99.0)
After cycle 2 treatment of dydrogesterone	65 (42)	59	90.8 (81.0-96.5)	64 (11)	59	92.1 (82.7-97.4)

¹Seven subjects in full analysis set and 5 subjects in per-protocol set who had a normal baseline menstrual cycle (defined as 21 d < menstrual-cycle ≤ 35 d) were not included for the statistical analysis. MC: Menstrual-cycle; FAS: Full analysis set; CI: Confidence interval; PPS: Per-protocol set.

Table 3 Sex hormone, lipid, insulin and blood glucose level after three cycles of treatment and biphasic basal body temperature during the treatment

Variables	FAS analysis			PPS analysis
	Baseline	End of treatment	P value	Baseline	End of treatment	P value
FSH (mIU/mL)	7.1 ± 3.0	6.9 ± 2.9	0.229	7.2 ± 3.0	6.9 ± 2.9	0.229
LH (mIU/mL)	10.4 ± 5.8	9.6 ± 6.0	0.095	10.8 ± 6.0	9.6 ± 6.0	0.095
PRL (mIU/mL)	11.3 ± 5.7	10.9 ± 4.3	0.449	11.4 ± 6.1	10.9 ± 4.3	0.449
E2 (mIU/mL)	59.7 ± 72.7	54.7 ± 98.0	0.809	51.9 ± 29.6	54.7 ± 98.0	0.809
T (mIU/mL)	0.58 ± 0.31	0.52 ± 0.19	0.010	0.59 ± 0.33	0.52 ± 0.19	0.010
DHEA-S (mIU/mL)	248.6 ± 114.7	231.3 ± 101.7	0.031	248.6 ± 110.8	231.3 ± 101.7	0.031
Patients with biphasic BBT after three cycles of treatment (%, 95%CI)		55 (21.2-45.1)			55 (21.2-45.1)
TC (mmol/L)	4.30 ± 0.80	4.12 ± 0.86	0.17	4.24 ± 0.80	4.13 ± 0.86	0.17
TG (mmol/L)	1.01 ± 0.59	1.03 ± 0.47	0.29	0.97 ± 0.59	1.03 ± 0.47	0.29
HDL (mmol/L)	1.02 ± 0.24	0.99 ± 0.28	0.54	1.01 ± 0.24	0.99 ± 0.28	0.54
LDL (mmol/L)	2.74 ± 0.54	2.53 ± 0.54	0.001	2.71 ± 0.54	2.53 ± 0.54	0.001
Lp (a1)	1.04 ± 0.21	1.25 ± 0.09	0.78	1.00 ± 0.21	1.26 ± 0.09	0.78
Lp (a2)	0.78 ± 0.16	0.71 ± 0.06	1.00	0.79 ± 0.19	0.71 ± 0.06	1.00
Insulin (µU/mL)	11.3 ± 8.4	10.5 ± 7.0	0.045	11.7 ± 8.9	10.5 ± 7.0	0.045
Glucose (mmol/L)	4.9 ± 0.9	4.7 ± 0.6	0.42	4.9 ± 1.1	4.7 ± 0.6	0.42

PRL: Prolactin; E2: Estrogen 2; LDL: Low-density lipoprotein; BBT: Basal body temperature; FSH: Follicle-stimulating hormone; LH: Luteinizing hormone; T: Testosterone; DHEA-S: Dehydroepiandrosterone sulfate; CI: Confidence interval.