Desogestrel

Overview

Desogestrel, a prodrug, is a third generation progestogen and hence, a member of the gonane family which was largely used in Europe before being approved in the US and Canada. It was firstly generated from a study that showed that 11-beta and 11-alkylidene substituent in nortestosterone can enhance the biological activity. Desogestrel is now produced semi-synthetically from naturally occurred plant steroids. In the US, desogestrel is found only in combination with ethinyl estradiol. The first approved drug containing desogestrel was developed by Organon USA Inc in 1972 and FDA approved in 1992.

Indication

Oral desogestrel is used in combination with ethinylestradiol as a contraceptive agent for the prevention of pregnancy. Desogestrel is part of the combined oral contraceptives that contain a mix of estrogen and progestin which inhibit ovulation.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Oral Contraceptive Pill (OCP) Pharmacogenomics	2024/03/28	NCT06334315	Phase 4	Recruiting	Yale University
Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?	2021/12/30	NCT05174195	Not Applicable	Terminated	University Hospital, Geneva
Desogestrel-containing COCP Pharmacokinetic Validation Study	2021/08/12	NCT05002738	Phase 4	Completed	University of Colorado, Denver
Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo	2021/06/28	NCT04941833	Phase 2	Completed	Rajavithi Hospital
Desogestrel Versus GnRH Antagonist in IVF/ICSI	2021/01/28	NCT04728659	Phase 4	UNKNOWN	Casa di Cura Privata Villa Mafalda
Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product	2020/06/09	NCT04422028	Phase 1	Completed	Laboratorios Andromaco S.A.
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors	2019/03/29	NCT03895099	Phase 3	Completed	Centre Hospitalier Intercommunal Creteil
Abnormal Uterine Bleeding and Progestin-only Contraceptives	2018/01/12	NCT03398811	N/A	Completed	Assiut University
Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors	2017/11/28	NCT03354494	N/A	Completed	Institut Universitari Dexeus
Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB	2014/04/04	NCT02103764	Phase 3	UNKNOWN	Mahidol University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MERCILON TABLET	N V ORGANON	SIN06136P	TABLET	0.15 mg	6/19/1991

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
BREDICON TABLETS 0.075MG	N/A	HIND WING COMPANY LIMITED	N/A	N/A	11/13/2022

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Desogestrel Ethinylestradiol-DWRN desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack	426652	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/12/2024
MADELINE desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack	202833	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/23/2013
Desogestrel Ethinylestradiol-RJIC desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack	426810	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/12/2024
MARVELON desogestrel / ethinylestradiol 28 tablets	42894	ORGANON PHARMA PTY LTD	Medicine	A	12/16/1992

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