Repros Therapeutics Inc.announced that the New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal, has...
Repros Therapeutics reported top line results for the first of two identical pivotal studies comparing Androxal (clomiphene) to a leading...
In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate. • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. • Follitropin alfa in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In adult men • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Treatment of female and male infertility in the following groups of patients: Anovulation, including polycystic ovarian disease (PCOD) in women who have been unresponsive to treatment with clomiphene citrate: - Women undergoing controlled ovarian hyperstimulation: MENOPUR can induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). - Hypogonadotrophic hypogonadism in men: MENOPUR may be given in combination with human chorionic gonadotrophin (e.g. Choragon) for the stimulation of spermatogenesis. Patients with primary testicular failure are usually unresponsive.
In adult women • Anovulation (including polycystic ovariansyndrome, PCOS) in women who have been unresponsive to treatment with clomiphene citrate. • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). • Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L. In adult men • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
In adult women • Anovulation (including polycystic ovariansnydrome, PCOS) in women who have been unresponsive to treatment with clomiphene citrate. • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). • Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L. In adult men • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.