Gestodene

also known as GSD · Gestodeno · SH B 331

Small molecule targets PGR via activation

Developed for: anovulation · polycystic ovary syndrome · adenomyosis · dysmenorrhea · endometriosis · female infertility
Investigated by: Bayer · Conselho Nacional de Desenvolvimento Científico e Tecnológico · Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. · Federal University of Rio Grande do Sul · Hospital de Clinicas de Porto Alegre · Mahidol University
+2 more
· Meir Medical Center · Parexel

Trials 16

today NCT03230825 · not/applicable NCT03077555 · Ph 4 NCT02550977 · Ph 2 NCT01204190 · Ph 2 NCT01083264 · Ph 1 NCT00896571 · Ph 2 NCT00915915 · Ph 2 NCT00920985 · Ph 3 NCT00933179 · Ph 2 NCT00984789 · Ph 3 NCT00910637 · Ph 3 NCT00873483 · Ph 2 NCT00914693 · Ph 3 NCT00729404 · Ph 2 NCT01372293 · not/applicable NCT00185354 · Ph 3

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT01083264	Oct 2009 → May 2010	—	Bayer	Completed	No outcome recorded
Phase 27 trials
Phase 2	NCT02550977	Sep 2015 → Jul 2016	—	Bayer	Completed	No outcome recorded
Phase 2	NCT01204190	Sep 2010 → Jul 2011	—	Bayer	Completed	No outcome recorded
Phase 2	NCT00896571	Jul 2009 → May 2011	—	Bayer	Completed	No outcome recorded
Phase 2	NCT00915915	Jun 2009 → Apr 2010	anovulation	Bayer	Completed	No outcome recorded
Phase 2	NCT00933179	Jun 2009 → Sep 2010	—	Bayer	Completed	No outcome recorded
Phase 2	NCT00873483	Apr 2009 → Mar 2010	—	Bayer	Completed	No outcome recorded
Phase 2	NCT00729404	Aug 2008 → Feb 2009	anovulation	Bayer	Terminated	No outcome recorded
Phase 35 trials
Phase 3	NCT00920985	Jun 2009 → Aug 2010	—	Bayer	Completed	No outcome recorded
Phase 3	NCT00910637	May 2009 → Dec 2010	—	Bayer	Completed	No outcome recorded
Phase 3	NCT00984789	May 2009 → Sep 2010	—	Bayer	Completed	No outcome recorded
Phase 3	NCT00914693	Apr 2009 → Sep 2011	—	Bayer	Completed	No outcome recorded
Phase 3	NCT00185354	Nov 2004 → Apr 2006	—	Bayer	Completed	No outcome recorded
Phase 41 trial
Phase 4	NCT03077555	Jan 2017 → Feb 2018	anovulation	Mahidol University	Completed	No outcome recorded
Phase not applicable2 trials
—	NCT03230825	Sep 2017 → Sep 2018	—	Meir Medical Center	Unknown	No outcome recorded
—	NCT01372293	Jan 2005 → Jan 2008	polycystic ovary syndrome	Federal University of Rio Grande do Sul	Completed	No outcome recorded
Comparator or background therapy7 trials
Phase 1/2	NCT03881904 Comparator	Jun 2017 → Jul 2019	female infertility	Ain Shams University	Unknown	No outcome recorded
Phase 1/2	NCT00517556 Comparator	Aug 2007 → Mar 2011	dysmenorrhea	Milton S. Hershey Medical Center	Completed	No outcome recorded
Phase 4	NCT03531437 Comparator	Mar 2016 → Jan 2018	thrombophilia	Mahidol University	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01056042 Comparator	Jun 2007 → Apr 2011	endometriosis	Prince of Songkla University	Completed	No outcome recorded
—	NCT06396221 Comparator	May → Sep 2024	anovulation	Chulalongkorn University	Completed	No outcome recorded
—	NCT06396208 Comparator	May → Oct 2024	anovulation	Chulalongkorn University	Completed	No outcome recorded
—	NCT03890042 Comparator	Mar 2019 → Jul 2020	adenomyosis	Assiut University	Completed	No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 26 sources stand behind the page.

Field	Value	Cited text
Known as	Gestodene	“treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles” NCT00517556 ↗ 22 “0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin)” NCT00185354 ↗ “quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene” NCT03077555 ↗ “7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen” NCT00896571 ↗ “Brand name :FLAME containing 0.02 mg Ethinylestradiol and 0.075 mg Gestodene.” NCT03230825 ↗ “ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles” NCT01372293 ↗ NCT00729404 ↗ NCT01204190 ↗ NCT00933179 ↗ NCT00910637 ↗ NCT00873483 ↗ Show 12 more sources
Known as	Gestodeno	ChEMBL registry synonym — accepted as the source's own label CHEMBL1213583 ↗
Known as	GSD	“The aim of this study was to investigate the bleeding pattern and cycle control of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD)...” PMID 25453585 ↗ Oct 2014 7 “OBJECTIVE(S): To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD)...” PMID 25453582 ↗ Oct 2014 “0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free...” NCT01204190 ↗ “7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen” NCT00896571 ↗ “7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen” NCT00914693 ↗ “Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene” NCT00915915 ↗ “Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)” NCT00185354 ↗ “Ethinylestradiol (EE) and Gestodene (GSD)” NCT01083264 ↗
Known as	SH B 331	ChEMBL registry synonym — accepted as the source's own label CHEMBL1213583 ↗
Action	Activate	“Progesterone receptor agonist” CHEMBL1213583 ↗
Action	Inhibit	“Inhibition of Ovulation” NCT00915915 ↗
Modality	Small molecule	— CHEMBL1213583 ↗
Route	Other	“contraceptive patch SH P00331F” NCT00185354 ↗
Target	PGR	“Progesterone receptor agonist” CHEMBL1213583 ↗