A trial to compare efficacy and safety of follitropin delta versus placebo (inactive treatment) in the treatment of men with idiopathic infertility (unexplained reduction of semen quality).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ferring Pharmaceuticals A/S

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

12 Jan 2023 → 23 Oct 2024

Decision date (initial)

2023-11-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-508430-34-00

EudraCT number

2021-004254-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To investigate the effect of FE 999049 treatment of men with idiopathic infertility on the chance of spontaneous pregnancy in their female partners.

Conditions and MedDRA coding

Idiopathic male infertility (including oligoasthenozoospermia).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. History of infertility for 12-60 months with current partner at randomisation
2. Men between the ages of 18 and 50 years
3. Total sperm count 5-39 million at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomisation
4. Total sperm motility of ≥10% at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomisation
5. Semen volume ≥1.4 mL at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomisation
6. Serum follicle-stimulating hormone (FSH) levels of 1.5-8.0 IU/L (measured at central laboratory) at screening
7. Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at central laboratory) at screening
8. Serum total testosterone levels of ≥300 ng/dL (equals ≥10.4 nmol/L; measured at central laboratory) at screening
9. Agree to have regular intercourse with current female partner with the intent of spontaneous conception within 9 months from randomisation
10. Agree to provide information on female partner's positive urine pregnancy test(s) and documentation of ultrasound(s), delivery, and neonatal/infant health
11. Current partner fulfilling the criteria below: a) Pre-menopausal woman between the ages of 18 and 35 years. b) Regular menstrual cycles of 21-35 days. c) No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation. d) Agree not to obtain infertility treatment outside of this trial for 9 months from randomisation of male subject.

Exclusion criteria 11

1. Previous FSH treatment not leading to conception
2. Past or current use of finasteride within 3 months prior to screening
3. Any history of anatomical disorder of the pituitary gland or testes
4. Any structural abnormalities of the vas deferens (unilateral or bilateral) at screening
5. Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact fertility
6. Known history or presence of clinical varicocele (subclinical and Grade 1 varicocele are acceptable)
7. Known history of cryptorchidism, testicular torsion, or orchitis
8. Known abnormal karyotype (including Y-chromosome microdeletion)
9. Current or past treatment of urogenital (kidney, bladder, testicular, or prostate) cancer as well as history of chemo- or radiotherapy that can have impact on testes
10. Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)
11. Administration of hormonal preparations, agents known to impair testicular function or affect sex hormone secretion, and known or suspected teratogens within 3 months prior to screening. Administration of anabolic steroids within 12 months prior to screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Spontaneous pregnancy observed in female partner within 9 months after randomisation of male subject, where spontaneous pregnancy is defined as vital pregnancy (documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ferring Pharmaceuticals A/S

Sponsor organisation

Ferring Pharmaceuticals A/S

Address

Amager Strandvej 405

City

Kastrup

Postcode

2770

Country

Denmark

Scientific contact point

Organisation

Ferring Pharmaceuticals A/S

Contact name

Sarah Grover

Public contact point

Organisation

Ferring Pharmaceuticals A/S

Contact name

Clinical and Translational Sciences

Locations

6 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications