Abbott Biologicals BV

To evaluate the real-world role of dydrogesterone for luteal phase support in ART, primarily assessed by ongoing pregnancy rate, defined as intrauterine live birth at 12 weeks' gestation as determined by ultrasonography.

The primary objective was to describe the pharmacokinetics (PK) of estradiol (E2), dydrogesterone (D) and their major metabolites [estrone (E1), estrone sulfate (E1S) and dihydrodydrogesterone (DHD)] after single and repeated oral administration of tablets containing 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone in healthy Chinese postmenopausal women. The secondary objective was to investigate the safety and tolerability of single and repeated oral administration of tablets containing 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone.

Primary objective: To demonstrate the efficacy of a continuous combination of 0.5 mg estradiol and 2.5 mg dydrogesterone over three 28-day cycles (12 weeks) for the treatment of vasomotor symptoms compared with placebo. Secondary objectives: To evaluate the bleeding pattern of a continuous combination regimen of 0.5 mg estradiol and 2.5 mg dydrogesterone; the effect on quality of life; and menopausal symptoms such as muscle and joint discomfort and mood disturbances. Safety objective: To evaluate the safety and tolerability of a continuous combination regimen containing 0.5 mg estradiol and 2.5 mg dydrogesterone.