Table 1.
Adverse events (AE) registered during hormone replacement therapy (HRT) in hypogonadal female TDT patients
HRT treatments | Number of patients treated-(percentage) |
Cyclic oral conjugated estrogen (CE: 0.3-0.625 mg daily, administered cyclically - e.g. three weeks on and one week off) combined with medroxyprogesterone acetate (MPA 5 mg in the last 12 days of CE) | 8/42 (19%) |
Ethinyl estradiol (30 μg ) + gestodene (0,075 mg) (EE+GSD) | 13/42 (30.9%) |
Ethinyl estradiol (20 μg) + desogestrel (0,15 mg) (EE+DSG) | 8/42 (19%) |
Transdermal estrogen (TE) patch (25-50 μg, administered cyclically - e.g. three weeks on and one week off) combined with medroxyprogesterone acetate (5 mg in the last 12 days of TE) | 9/42 (21.4%) |
Vaginal ring (ethinyl estradiol/ etonogestrel) AE and HRT | 4/42 (9.5%) |
Skin irritation at the application site or discomfort on patch removal (TE) | 4/9 (44.4%) |
Partial patch detachment under conditions of heat, humidity, and exercise or partial peeling of the patch corner (TE) | 3/9 (33.3%) |
Mild breast tenderness (EE+GSD) | 4/42 (9.5%) |
Shorter duration of bleeding in patients with secondary amenorrhea (CE+ MPA and EE+DSG) | 5/42 (11.9%) |
Failure of endometrium to respond to estrogen (see results) | 3/42 (7.1%) |
Deterioration of glucose tolerance from normal to impaired (3 patients) from impaired to diabetes (1 patient) (EE+DSG and EE+DSG) | 4/42 (9.5%) |
Melasma of face (EE+DSG and EE+DSG) | 3/42 (7.1%) |
Acne (EE+DSG and EE+DSG) | 3/42 (7.1%) |
Fluid retention (EE+GSD) | 2/42 (4.6%) |
Mild elevation of liver enzymes (EE+DSG and EE+DSG) | 3/42 (7.1%) |
Mild elevation of total bilirubin (EE+DSG and EE+DSG) | 3/42 (7.1%) |
Mild elevation of lipids (EE+DSG and EE+DSG) | 3/42 (7.1%) |
Headache (EE+GSD) | 2/42 (4.6%) |
Unusual weight gain (>3 kg) (EE+GSD) | 1/42 (2.3%) |
Stroke (HRT: see results) | 1/42 (2.3%) |
Retinal artery spasm (HRT: see results) | 1/42 (2.3%) |