progesterone / IBSA Institute Biochemical SA, Cedars-Sinai - LARVOL DELTA

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3 | N=680 | Active, not recruiting | Sponsor: IBSA Institut Biochimique SA | Recruiting ➔ Active, not recruiting

Enrollment closed • Infertility • Sexual Disorders

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3 | N=680 | Recruiting | Sponsor: IBSA Institut Biochimique SA | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Infertility • Sexual Disorders

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3 | N=680 | Recruiting | Sponsor: IBSA Institut Biochimique SA | Trial completion date: Mar 2025 ➔ Apr 2026 | Trial primary completion date: Sep 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3 | N=680 | Recruiting | Sponsor: IBSA Institut Biochimique SA | Trial completion date: Sep 2024 ➔ Mar 2025 | Trial primary completion date: Feb 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

SexVAP: Sexual Intercourse and Vaginal Absorption of Progesterone (clinicaltrials.gov) - P=N/A | N=40 | Completed | Sponsor: University Hospital, Montpellier | Recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Feb 2024

Trial completion • Trial completion date • Infertility • Sexual Disorders

Comparative Bioavailability of Two Daily Subcutaneous Doses Versus a Single Dose of Intramuscular and Vaginal Progesterone Formulations in Healthy Postmenopausal Females. (PubMed, Clin Pharmacol Drug Dev) - "Mild injection site reactions were reported with similar frequency for SC and IM progesterone. With further research, twice-daily SC progesterone may offer an alternative to existing available treatments for luteal phase support."

Journal

Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX) (clinicaltrials.gov) - P2 | N=213 | Completed | Sponsor: IBSA Institut Biochimique SA | Recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Dec 2022

Trial completion • Trial completion date • Infertility • Sexual Disorders

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3 | N=680 | Recruiting | Sponsor: IBSA Institut Biochimique SA | Not yet recruiting ➔ Recruiting | Trial completion date: May 2024 ➔ Sep 2024 | Trial primary completion date: Oct 2023 ➔ Feb 2024

Enrollment open • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX) (clinicaltrials.gov) - P2 | N=212 | Recruiting | Sponsor: IBSA Institut Biochimique SA | Trial completion date: Apr 2022 ➔ Apr 2023 | Trial primary completion date: Jan 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: IBSA Institut Biochimique SA | Trial completion date: Apr 2023 ➔ May 2024 | Trial primary completion date: Jan 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3; N=600; Not yet recruiting; Sponsor: IBSA Institut Biochimique SA; Trial completion date: Sep 2022 ➔ Apr 2023; Initiation date: Jun 2021 ➔ Jan 2022; Trial primary completion date: Jun 2022 ➔ Jan 2023

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Infertility • Sexual Disorders

Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX) (clinicaltrials.gov) - P2; N=212; Recruiting; Sponsor: IBSA Institut Biochimique SA; Trial completion date: Oct 2021 ➔ Apr 2022; Trial primary completion date: Jun 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3; N=600; Not yet recruiting; Sponsor: IBSA Institut Biochimique SA; Initiation date: Nov 2020 ➔ Jun 2021; Trial primary completion date: Mar 2022 ➔ Jun 2022

Clinical • Trial initiation date • Trial primary completion date • Infertility • Sexual Disorders

Progesterone for the Treatment of COVID-19 in Hospitalized Men (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Sara Ghandehari; Active, not recruiting ➔ Completed; Trial completion date: Apr 2021 ➔ Aug 2020

Clinical • Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Progesterone for the Treatment of COVID-19 in Hospitalized Men (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Sara Ghandehari; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

PROGRESS: Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (clinicaltrials.gov) - P3; N=600; Not yet recruiting; Sponsor: IBSA Institut Biochimique SA

Clinical • New P3 trial • Infertility • Sexual Disorders

Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX) (clinicaltrials.gov) - P2; N=212; Recruiting; Sponsor: IBSA Institut Biochimique SA; Trial completion date: Jan 2020 ➔ Oct 2021; Trial primary completion date: Oct 2019 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Infertility • Long-acting Reversible Contraceptives • Sexual Disorders

Study examines progesterone to reduce inflammation in Covid-19 (Healio) - "The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 among hospitalized men. This will be a randomized controlled trial enrolling 40 men with confirmed COVID-19....Half the men will receive standard care and half will receive 100 mg subcutaneous progesterone twice daily, in the abdomen or arm, for 5 days. Primary outcome is clinical status of participants at day 15....We will assess their clinical status after receiving the medication. We are looking at how they were when they started, and how they progressed on treatment....We presented this to FDA, and FDA allowed us to perform a clinical trial..."

Cytokine storm • New trial • Infectious Disease • Novel Coronavirus Disease