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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merckle GmbH
• Treatments: Goserelin

Criteria

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