A Phase 1, open label, randomized, 2-sequence, 2-period, crossover, single center study to evaluate the pharmacokinetics of follitropin alfa from 2 manufacturing processes, administered as a single subcutaneous 450 IU dose to pituitary-suppressed healthy premenopausal female participants.

Start 19 Mar 2024 · End 1 Oct 2024 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol MS700623_0061

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 14

Countries 1

Sites 1

Infertility

Key facts

Sponsor: Merck Healthcare KGaA
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trial duration: 19 Mar 2024 → 1 Oct 2024
Decision date (initial): 2024-02-15
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Infertility

Version	Level	Code	Term	System organ class
20.0	PT	10021928	Infertility female	100000004872

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Healthcare KGaA

Sponsor organisation: Merck Healthcare KGaA
Address: Frankfurter Strasse 250
City: Darmstadt
Postcode: 64293
Country: Germany

Scientific contact point

Organisation: Merck Healthcare KGaA
Contact name: Merck Healthcare KGaA

Public contact point

Organisation: Merck Healthcare KGaA
Contact name: Merck Healthcare KGaA

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Netherlands	Ended	14	1
Rest of world	—	0	—

Investigational sites

Netherlands

1 site · Ended

Pharmaceutical Research Associates Group B.V.

Program Management, Van Swietenlaan 6, 9728 NZ, Groningen

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Netherlands	2024-03-19	2024-10-01	2024-04-02	2024-09-09

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-12-11	Netherlands	Acceptable 2024-02-15	2024-02-15