Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)
NCT ID: NCT04654039
Last Updated: 2025-04-01
Study Results
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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COMPLETED
728 participants
OBSERVATIONAL
2020-10-26
2023-10-28
Brief Summary
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It was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (AEs) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment of Infertility
Non intervention
Other: Non intervention
Non intervention
Interventions
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Other: Non intervention
Non intervention
Eligibility Criteria
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Inclusion Criteria
* Participants who have consented to personal information use
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu
Anyang, , South Korea
Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup
Asan, , South Korea
Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu
Busan, , South Korea
Eroom women's clinic, 25, Seomyeon-ro, Busanjin-gu
Busan, , South Korea
Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu
Daejeon, , South Korea
Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu
Gwangju, , South Korea
Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu
Gwangju, , South Korea
Design Hospital
Jeonju, , South Korea
Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro
Sejong, , South Korea
CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu
Seongnam, , South Korea
Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu
Seongnam, , South Korea
M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu
Seoul, , South Korea
MariaS (Sangbong), 267, Mangu-ro, Jungnang-gu
Seoul, , South Korea
Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu
Seoul, , South Korea
Seoul Maria Fertility Hospital, 20, Cheonho-daero, Dongdaemun-gu
Seoul, , South Korea
Countries
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Other Identifiers
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000385
Identifier Type: -
Identifier Source: org_study_id
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