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

NCT ID: NCT02592031

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XM17

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

Group Type EXPERIMENTAL

XM17

Intervention Type DRUG

300 IU corresponds to an injection volume of 0.5 mL.

Gonal-f®

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

Group Type EXPERIMENTAL

Gonal-f®

Intervention Type DRUG

300 IU corresponds to an injection volume of 0.5 mL.

Zoladex®

Zoladex® 3.6 mg will be administered by subcutaneous injection

Group Type ACTIVE_COMPARATOR

Zoladex®

Intervention Type DRUG

3.6 mg

Interventions

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XM17

300 IU corresponds to an injection volume of 0.5 mL.

Intervention Type DRUG

Gonal-f®

300 IU corresponds to an injection volume of 0.5 mL.

Intervention Type DRUG

Zoladex®

3.6 mg

Intervention Type DRUG

Other Intervention Names

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follitropin alfa goserelin acetate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merckle GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

References

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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.

Reference Type DERIVED
PMID: 26621118 (View on PubMed)

Other Identifiers

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2008-005756-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

XM17-02

Identifier Type: -

Identifier Source: org_study_id