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CompletedNCT02592031Updated Nov 9, 2021

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

A Phase 1 interventional study of XM17 and Gonal-f® in Bioequivalence, sponsored by Merckle GmbH. Completed. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-09.

Sponsored by Merckle GmbH · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
Female
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Study 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.

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Conditions studied

  • Bioequivalence
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In context

Lead sponsor

Merckle GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    XM17

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

    Drug: XM17

  • Experimental
    Gonal-f®

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

    Drug: Gonal-f®

  • Active comparator
    Zoladex®

    Zoladex® 3.6 mg will be administered by subcutaneous injection

    Drug: Zoladex®

Interventions

  • DrugXM17

    300 IU corresponds to an injection volume of 0.5 mL.

  • DrugGonal-f®

    300 IU corresponds to an injection volume of 0.5 mL.

    Also known as: follitropin alfa

  • DrugZoladex®

    3.6 mg

    Also known as: goserelin acetate

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What researchers measure

Primary outcomes

  1. Comparison of single dose pharmacokinetics (Cmax)

    XM17 and Gonal-f® tested statistically for bioequivalence.

    Time frame: 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

  2. Comparison of single dose pharmacokinetics (AUC0-t)

    XM17 and Gonal-f® tested statistically for bioequivalence.

    Time frame: 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

  1. Pharmacokinetics AUC0-∞

    Area under the XM17 / Gonal-f® concentration time curve from time 0 extrapolated to infinity

    Time frame: 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

  2. Pharmacokinetics AUC0-168h

    Area under the XM17 / Gonal-f® concentration time curve from time 0 to 168 h

    Time frame: 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

  3. Pharmacokinetics Cmax,obs

    Maximum XM17 / Gonal-f® concentration determined during the interval of sample taking

    Time frame: 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. Pharmacokinetics Tmax

    Time to maximum XM17 / Gonal-f® concentration

    Time frame: 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

  5. Pharmacokinetics λZ

    Apparent terminal elimination rate constant.

    Time frame: 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

  6. Pharmacokinetics t1/2

    Apparent terminal elimination half life.

    Time frame: 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

  7. Pharmacokinetics CL/F

    Serum clearance after dosing

    Time frame: 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

  8. Pharmacokinetics Vz/F

    Volume of Distribution during the terminal phase after extravascular administration

    Time frame: 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

  9. Percentage of participants with adverse events

    Time frame: Signing of informed consent to final data collection (27 days)

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26621118 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02592031
Lead sponsor
Merckle GmbH
Responsible party
Sponsor
First posted
Oct 30, 2015
Start date
Feb 2009
Primary completion
May 2009
Completion
Dec 2009
Last update
Nov 9, 2021

Study contacts

Teva Medical Expert, MD
study director · Teva Branded Pharmaceutical Products R&D, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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