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

Merckle

Status and phase: Completed; Phase 1

Conditions: Bioequivalence

Treatments: Drug: Gonal-f®; Drug: Zoladex®; Drug: XM17

Study type: Interventional

Funder types: Industry

Identifiers

NCT02592031

2008-005756-24 (EudraCT Number)

XM17-02

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

XM17

Experimental group

Description:

XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL.

Treatment:

Drug: XM17

Gonal-f®

Experimental group

Description:

Gonal-f® will be provided in pens with integrated vials of 0.5 mL

Treatment:

Drug: Gonal-f®

Zoladex®

Active Comparator group

Description:

Zoladex® 3.6 mg will be administered by subcutaneous injection

Treatment:

Drug: Zoladex®