Progesterone for Androgen Syndrome during Puberty

(CRM003 Trial)

This trial tests whether progesterone, a natural hormone, can help manage hormone levels in girls undergoing puberty. It examines how progesterone affects luteinizing hormone (LH) in girls with and without signs of excessive male hormones, such as extra hair growth, during puberty. Girls in mid- to late-stage puberty, with or without signs of excessive male hormones, and in generally good health, may qualify for this study. Participants will receive either micronized progesterone suspension or a placebo to observe their body's response. As an Early Phase 1 trial, this research aims to understand how progesterone functions in people, offering participants the chance to contribute to groundbreaking insights.

Yes, you will need to stop taking any medications that affect the reproductive system, glucose metabolism, lipid metabolism, or blood pressure at least 2 months before the screening visit and 3 months before starting the study medications. This includes oral contraceptives, progestins, metformin, systemic glucocorticoids, some antipsychotics, and stimulants like methylphenidate.

Research has shown that micronized progesterone is generally safe. Studies have found it to be well-tolerated by most people, meaning it usually doesn't cause problems. Importantly, it does not increase the risk of breast cancer.

One study discovered that the body quickly absorbs micronized progesterone, and it works well compared to other hormone treatments. While absorption may vary among individuals, it typically doesn't cause serious side effects.

Micronized progesterone suspension is unique because it introduces a natural hormone, progesterone, as a potential treatment for Androgen Syndrome during puberty. Unlike standard treatments that may focus on managing symptoms with synthetic hormones or other medications, this approach uses progesterone in a micronized form, which may enhance absorption and effectiveness. Researchers are excited about this treatment because it could offer a more natural and possibly more effective way to balance hormone levels and manage the symptoms of Androgen Syndrome during a critical developmental period.

This trial will compare micronized progesterone suspension with a placebo. Studies have shown that micronized progesterone can be beneficial in several ways. Specifically, it improves satisfaction with breast development, which is important for individuals undergoing gender affirmation therapy. Additionally, it is safe for most people. However, it does not significantly alter male hormone levels when taken orally. While it may not lower certain male hormones, it offers other benefits and is generally well-tolerated.²⁶⁷⁸⁹