Gestodene Clinical Trials

Clinical Trials

Multiple completed clinical trials have evaluated gestodene for female contraception, suppression of ovarian activity, and bioequivalence. Sponsored by major pharmaceutical companies including Bayer and Pfizer, these Phase 1 and Phase 2 studies investigated oral and transdermal patch formulations combining gestodene with ethinylestradiol to assess ovulation inhibition and relative bioavailability. Overall, this clinical portfolio demonstrates robust development focused on optimizing reproductive hormone delivery and contraceptive efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02550977	Completed	Contraception	Bayer	2015-09-18	Phase 2
NCT01260805	Completed	Bioequivalence\|Ethinylestradiol\|Gestodene\|Harmonet	Pfizer	2010-09	Phase 1
NCT01204190	Completed	Contraception	Bayer	2010-09	Phase 2
NCT01083264	Completed	Contraception	Bayer	2009-10	Phase 1
NCT00915915	Completed	Contraception\|Ovulation Inhibition	Bayer	2009-06	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Gestodene product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gestodene selectively binds to progesterone receptors in target tissues, where it exerts potent negative feedback on the hypothalamic-pituitary-ovarian axis to suppress gonadotropin secretion. Consequently, this suppression prevents the preovulatory surge of luteinizing hormone and alters cervical mucus integrity, thereby inhibiting ovulation and providing reliable female contraception as demonstrated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).