NCT02592031

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

October 28, 2015

Last Update Submit

November 5, 2021

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (2)

  • Comparison of single dose pharmacokinetics (Cmax)

    XM17 and Gonal-f® tested statistically for bioequivalence.

    Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose

  • Comparison of single dose pharmacokinetics (AUC0-t)

    XM17 and Gonal-f® tested statistically for bioequivalence.

    Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose

Secondary Outcomes (9)

  • Pharmacokinetics AUC0-∞

    Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose

  • Pharmacokinetics AUC0-168h

    Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose

  • Pharmacokinetics Cmax,obs

    Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose

  • Pharmacokinetics Tmax

    Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose

  • Pharmacokinetics λZ

    Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose

  • +4 more secondary outcomes

Study Arms (3)

XM17

EXPERIMENTAL

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

Drug: XM17

Gonal-f®

EXPERIMENTAL

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

Drug: Gonal-f®

Zoladex®

ACTIVE COMPARATOR

Zoladex® 3.6 mg will be administered by subcutaneous injection

Drug: Zoladex®

Interventions

XM17DRUG

300 IU corresponds to an injection volume of 0.5 mL.

XM17
Gonal-f®DRUG

300 IU corresponds to an injection volume of 0.5 mL.

Also known as: follitropin alfa
Gonal-f®
Zoladex®DRUG

3.6 mg

Also known as: goserelin acetate
Zoladex®

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having signed written informed consent
  • Healthy female subjects of any racial origin
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lammerich A, Mueller A, Bias P. Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f(R) in healthy women after follicle-stimulating hormone downregulation. Reprod Biol Endocrinol. 2015 Dec 1;13:130. doi: 10.1186/s12958-015-0124-y.

    PMID: 26621118DERIVED

MeSH Terms

Interventions

follitropin alfaGoserelin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Teva Medical Expert, MD

    Teva Branded Pharmaceutical Products R&D, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 30, 2015

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Study Completion

December 1, 2009

Last Updated

November 9, 2021

Record last verified: 2021-11