October 17, 2023 - The Phase III controlled study would be the most advanced study ever conducted for gender-affirming care.

The goal of this development program is a stand-alone form of estradiol with a singular indication for people with gender incongruence.

“The FDA’s recognition of our proposal and provision of an acceptable program is an acknowledgement of the essential medical care that gender-affirming hormones provide. Our next step is to secure funding to conduct our program with estradiol as outlined by FDA,” said Nicole J. LaRocque, Founder and Chief Operating Officer of RIGT. 

By Theresa Gaffney

Now, for the first time, a nonprofit group is pursuing research with the goal of FDA approval for the use of estrogen as a gender-affirming treatment for trans and gender-diverse patients.

FDA approval of hormone therapies for gender-affirming care wouldn't change the way doctors prescribe them or patients use them, but it would bring additional legitimacy to the treatment and could make insurance companies more willing to cover the drugs, said Madeline Deutsch, director of the University of California, San Francisco's Gender Affirming Health Program.

But FDA approval could have massive implications outside of the doctor’s office. “Currently, access to gender-affirming care is under examination in the court of law and the court of public opinion,” Dr. Madeline Deutsch, medical director of the University of California, San Francisco’s Gender Affirming Health Program, told Prescription Pulse.