Trial | NCT02592031  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    49
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.
Study Started
Feb 28
2009
Primary Completion
May 31
2009
Study Completion
Dec 31
2009
Last Update
Nov 09
2021

Drug XM17

300 IU corresponds to an injection volume of 0.5 mL.

Drug Gonal-f®

300 IU corresponds to an injection volume of 0.5 mL.

  • Other names: follitropin alfa

Drug Zoladex®

3.6 mg

  • Other names: goserelin acetate

XM17 Experimental

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

Gonal-f® Experimental

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

Zoladex® Active Comparator

Zoladex® 3.6 mg will be administered by subcutaneous injection

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
No Results Posted