Norelgestromin
- Generic Name
- Norelgestromin
- Brand Names
- Evra, Xulane, Zafemy
- Drug Type
- Small Molecule
- Chemical Formula
- C21H29NO2
- CAS Number
- 53016-31-2
- Unique Ingredient Identifier
- R0TAY3X631
- Background
Norelgestromin is a drug used in contraception. Norelgestromin is the active progestin responsible for the progestational activity that occurs in women after application of ORTHO EVRA patch.
- Indication
Norelgestromin is used for contraception and menopausal hormonal therapy. Norelgestromin may potentially be used in breast cancer treatment due to its inhibitory effect on estrone sulfatase . They convert sulfated steroid precursors to estrogen during pregnancy.
- Associated Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Associated Therapies
- Transdermal contraception therapy
A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
- First Posted Date
- 2019-07-12
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 68
- Registration Number
- NCT04017195
- Locations
- 🇩🇪
Charite - Universitaetsmedizin Berlin (CCM), Berlin, Germany
🇧🇪SGS Belgium NV, Antwerpen, Belgium
🇳🇱PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini, Groningen, Netherlands
A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women
Phase 4
Completed
- Conditions
- Healthy
- Interventions
- Drug: HMW PIB patch (NGMN+EE) (Treatment B) (Test)
- First Posted Date
- 2017-09-06
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 70
- Registration Number
- NCT03274297
- Locations
- 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium
Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity
Phase 2
- Conditions
- Contraception
- Interventions
- First Posted Date
- 2007-02-26
- Last Posted Date
- 2011-02-14
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 36
- Registration Number
- NCT00439972
- Locations
- 🇺🇸
University of Washington, Northwest Lipid Research Clinic, Seattle, Washington, United States
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
Phase 4
Completed
- Conditions
- ContraceptionFemale Contraception
- First Posted Date
- 2005-12-05
- Last Posted Date
- 2010-11-16
- Lead Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Target Recruit Count
- 778
- Registration Number
- NCT00261482
A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)
Phase 1
Completed
- Conditions
- ContraceptionFemale Contraception
- First Posted Date
- 2005-11-24
- Last Posted Date
- 2011-06-08
- Target Recruit Count
- 60
- Registration Number
- NCT00258063
A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)
Phase 1
Completed
- Conditions
- ContraceptionFemale Contraception
- Interventions
- First Posted Date
- 2005-11-24
- Last Posted Date
- 2012-12-12
- Target Recruit Count
- 53
- Registration Number
- NCT00258076
A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers
Phase 1
Completed
- Conditions
- ContraceptionFemale Contraception
- First Posted Date
- 2005-11-17
- Last Posted Date
- 2011-06-08
- Target Recruit Count
- 34
- Registration Number
- NCT00254865
A Study of Efficacy and Safety With the Transdermal Contraceptive System.
Phase 3
Completed
- Conditions
- ContraceptionFemale Contraception
- First Posted Date
- 2005-10-12
- Last Posted Date
- 2010-11-17
- Target Recruit Count
- 1751
- Registration Number
- NCT00236769
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.
Phase 3
Completed
- Conditions
- Contraception
- First Posted Date
- 2005-10-12
- Last Posted Date
- 2011-06-08
- Target Recruit Count
- 1517
- Registration Number
- NCT00236782
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.
Phase 3
Completed
- Conditions
- ContraceptionFemale Contraception
- First Posted Date
- 2005-10-12
- Last Posted Date
- 2011-06-08
- Target Recruit Count
- 1494
- Registration Number
- NCT00236795
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