Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)

Last updated: March 27, 2025
Sponsor: Ferring Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Infertility

Treatment

Other: Non intervention

Clinical Study ID

NCT04654039
000385
  • Ages 18-65
  • Female

Study Summary

This post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of Food and Drug Safety [MFDS]: Notification No. 2017-95, 21 Nov, 2017).

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who were prescribed with REKOVELLE (follitropin delta) for the firsttime according to the approved administration method and dose

  • Participants who have consented to personal information use

Exclusion

Exclusion Criteria:

  • Participants who are prohibited from use according to the special warnings andprecautions for use of REKOVELLE (follitropin delta)

Study Design

Total Participants: 728
Treatment Group(s): 1
Primary Treatment: Other: Non intervention
Phase:
Study Start date:
October 26, 2020
Estimated Completion Date:
October 28, 2023

Connect with a study center

  • Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu

    Anyang,
    Korea, Republic of

    Site Not Available

  • Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup

    Asan,
    Korea, Republic of

    Site Not Available

  • Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu

    Busan,
    Korea, Republic of

    Site Not Available

  • Eroom women's clinic, 25, Seomyeon-ro, Busanjin-gu

    Busan,
    Korea, Republic of

    Site Not Available

  • CHA Daegu Women's Medical Center Women's 2095, Dalgubeol-daero, Jung-gu

    Daegu,
    Korea, Republic of

    Site Not Available

  • Joymom Infertility Clinic, 359, Jungang-daero, Jung-gu

    Daegu,
    Korea, Republic of

    Site Not Available

  • Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Design Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

  • Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro

    Sejong,
    Korea, Republic of

    Site Not Available

  • CHA univerity Bundang medical center, 59, Yatap-ro, Bundang-gu

    Seongnam,
    Korea, Republic of

    Site Not Available

  • CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu

    Seongnam,
    Korea, Republic of

    Site Not Available

  • M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu

    Seoul,
    Korea, Republic of

    Site Not Available

  • MariaS (Sangbong), 267, Mangu-ro, Jungnang-gu

    Seoul,
    Korea, Republic of

    Site Not Available

  • Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul Maria Fertility Hospital, 20, Cheonho-daero, Dongdaemun-gu

    Seoul,
    Korea, Republic of

    Site Not Available

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