Estrace topical (estradiol) / AbbVie - LARVOL DELTA

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone (clinicaltrials.gov) - P=N/A; N=11; Active, not recruiting; Sponsor: University of Virginia; Trial completion date: Dec 2018 ➔ Dec 2019; Trial primary completion date: Jun 2018 ➔ Jun 2019

Trial completion date • Trial primary completion date • Biosimilar • Polycystic Ovarian Syndrome

JCM026: Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition (clinicaltrials.gov) - P=N/A; N=10; Active, not recruiting; Sponsor: University of Virginia; Trial primary completion date: Jan 2018 ➔ Nov 2018

Trial primary completion date • Biosimilar • Polycystic Ovarian Syndrome

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone (clinicaltrials.gov) - P=N/A; N=11; Active, not recruiting; Sponsor: University of Virginia; Trial primary completion date: Dec 2016 ➔ Jun 2018

Trial primary completion date • Biosimilar • Polycystic Ovarian Syndrome

Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition (clinicaltrials.gov) - P=N/A; N=10; Active, not recruiting; Sponsor: University of Virginia; Trial primary completion date: Nov 2018 ➔ Dec 2019

Trial primary completion date

REPLENISH: A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms (clinicaltrials.gov) - P3; N=1750; Active, not recruiting; Sponsor: TherapeuticsMD; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar

Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy (clinicaltrials.gov) - P3; N=535; Recruiting; Sponsor: Prasco LLC

New P3 trial • Biosimilar

Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women (clinicaltrials.gov) - P=N/A; N=30; Not yet recruiting; Sponsor: Intira Sriprasert; Initiation date: Aug 2014 ➔ Oct 2015; Trial primary completion date: Aug 2015 ➔ Oct 2016

Clinical • Trial initiation date • Trial primary completion date

Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women (clinicaltrials.gov) - P3; N=20; Completed; Sponsor: Intira Sriprasert; Recruiting ➔ Completed; Phase classification: PN/A ➔ P3; N=30 ➔ 20; Trial completion date: Aug 2017 ➔ Aug 2018; Trial primary completion date: Dec 2016 ➔ Aug 2018

Clinical • Enrollment change • Phase classification • Trial completion • Trial completion date • Trial primary completion date

Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women (clinicaltrials.gov) - P=N/A; N=30; Recruiting; Sponsor: Intira Sriprasert; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women (clinicaltrials.gov) - P=N/A; N=30; Not yet recruiting; Sponsor: Intira Sriprasert

Clinical

Pilot E2 for Hypogonadal Women With CFBD (clinicaltrials.gov) - P4; N=0; Withdrawn; Sponsor: Emory University; N=52 ➔ 0; Recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal

Pilot E2 for Hypogonadal Women With CFBD (clinicaltrials.gov) - P4; N=52; Recruiting; Sponsor: Emory University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

"Acerus Announces Reporting of Anticipated Shortage of ESTRACE® https://t.co/spdAly2Vh7" (@NewsFromBW)