Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

An Open, Randomized, Two-way Cross-over Phase I Study to Compare the Bioavailability, Safety and Tolerability of Single s.c. Doses of 300 IU XM17 With 300 IU Gonal-f® in 36 Healthy, Down-regulated Young Women

Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects. Only female subjects will be included in the study to reach the objectives of the study.

Inclusion Criteria:

• Having signed written informed consent
• Healthy female subjects of any racial origin
• 18-39 years at the time of screening
• Body mass index (BMI) between 18-29 kg/m2 and a body weight of ≥ 50 kg
• Use of oral contraceptives for contraceptive purposes only and not for regularization of menstrual cycle, for at least 3 months
• Normal uterus and two functioning ovaries
• Agrees to use an adequate method of contraception during the study
• Non-smoking or moderate smokers of < 10 cigarettes a day

Exclusion Criteria:

• Pregnancy
• Polycystic ovary syndrome, impaired ovarian function, severe endometriosis class III or IV, submucosal myoma uteri
• History of endocrine abnormalities with treatment within the last six months.
• Contraindications for the use of gonadotropins and goserelin
• Breast-feeding or being within a period of 2 months after delivery or abortion.
• Use of an injectable hormonal contraceptive within a period of 6 months prior to screening
• Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ