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

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04654039
• Collaborator: (none)
• Enrollment: 600
• Locations: 8
• Anticipated Duration (Months): 36.1
• Patients Per Site: 75
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

This post-marketing surveillance study is 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 is 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Other: Other: Non intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen(Follitropin Delta)
• Actual Study Start Date: Oct 26, 2020
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Treatment of Infertility Non intervention	Other: Other: Non intervention; Non intervention

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects with serious AEs and adverse drug reactions (ADRs) [Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination]

2. Proportion of subjects with unexpected AEs/ADRs not reflected in 'Precautions for Use' [Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination]

3. Proportion of subjects with expected ADRs [Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination]

4. Proportion of subjects with non-serious ADRs [Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination]

5. Proportion of subjects with ovarian hyperstimulation syndrome (OHSS) [Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination]

6. Technical malfunction of REKOVELLE pre-filled pen [Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination]

Secondary Outcome Measures

1. Number of the oocytes retrieved [At the oocyte retrieval visit, after completion of controlled ovarian stimulation and approximately 36 hours after human chorionic gonadotropin (hCG) administration.]

2. Ongoing pregnancy rate in women undergoing controlled ovarian stimulation [Between 10-11 weeks after embryo transfer]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose

• Patients who have consented to personal information use

Exclusion Criteria:

• Patients who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu	Busan		Korea, Republic of
2	Joymom Infertility Clinic, 359, Jungang-daero, Jung-gu	Daegu		Korea, Republic of
3	Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu	Daejeon		Korea, Republic of
4	Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu	Gwangju		Korea, Republic of
5	Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu	Gwangju		Korea, Republic of
6	Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro	Sejong		Korea, Republic of
7	M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu	Seoul		Korea, Republic of
8	Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu	Seoul		Korea, Republic of

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04654039
• Other Study ID Numbers: 000385
• First Posted: Dec 4, 2020
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ferring Pharmaceuticals: Follitropin Delta; REKOVELLE
• Additional relevant MeSH terms: Infertility; Infertility, Female

Study Results

No Results Posted as of May 18, 2022