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Going bald isn’t just a problem for men. Millions of women also face hereditary hair loss that can be embarrassing or stressful, with only one FDA-approved medication to help them.

But now a promising new treatment might be coming down the pipeline.

According to an article published in the International Journal of Dermatology, a recent pilot study found that a novel combination therapy for female pattern hair loss was safe and effective.

One hundred women with female pattern hair loss took part in the study.

Once a day over 12 months, each woman took a capsule that contained 25 milligrams (mg) of spironolactone and 0.25 mg of oral minoxidil.

When taken separately, each of these drugs can help prevent hair loss from getting worse and promote hair growth in some women.

When taken together, they might have even greater benefits.

“The combination of spironolactone together with minoxidil was well tolerated by almost all women, arrested hair loss, and actually regrew hair in most women,” Dr. Rod Sinclair, author of the study and head of DIRECT, the Dermatology Investigational Research, Education, and Clinical Trials Centre at Sinclair Dermatology, told Healthline.

Within three months of starting treatment, most participants noticed they were shedding less hair.

Within six months of starting treatment, most had improved hair density.

To follow up on this pilot study, Sinclair has begun phase II clinical trials.

He expects those trials to wrap up within six months.

“Once we have the results from the phase II trials,” he said, “we plan to approach the FDA Centre for Drug Evaluation for a pre-IND [investigational new drug] meeting to map out the path for evaluation and development of this treatment so that is can be made available to women affected by hair loss in the U.S. and worldwide.”

Most reported side effects were mild

This pilot study makes a solid contribution to the field of female pattern hair loss, Dr. Amy McMichael, chair of dermatology at the Wake Forest School of Medicine, told Healthline.

“I believe this is a solid article that adds a lot to the literature,” McMichael said.

“His use of an accepted visual scale is helpful in determining the improvement [in hair shedding and density] in a scientific manner,” she added.

To visually assess hair shedding and density among participants, Sinclair’s team used clinical grading scales that he had developed and validated in previous studies.

They also checked for side effects by asking participants about potential symptoms, checking their blood pressure at each visit, and conducting regular blood tests.

Eight of the women who took part in the study developed side effects, including hives, facial hair growth, or low blood pressure when standing.

But these side effects were generally mild, and only two women stopped treatment early.

To limit the risk of side effects associated with oral minoxidil, Sinclair and his team administered it in low doses.

Nonetheless, some patients may need to adjust their medication regimen before adding minoxidil or spironolactone to it.

“Both minoxidil and spironolactone are prescription medications, with a number of drug interactions. People already undergoing treatment for high blood pressure, fluid retention, or palpitations may require modification of their existing medications,” Sinclair cautioned.

FDA-approved treatment options are limited

Currently, the only FDA-approved treatment for female pattern hair loss is topical minoxidil.

It’s available as a 2 percent solution, a 5 percent solution, or a foam that can applied to the scalp.

Other non-FDA-approved treatments include oral 5-alpha-reductase inhibitors, platelet-rich plasma injections, low-level laser therapy, and surgical hair transplantation.

Psychosocial counselling may also help some women cope with the potential social and emotional effects of hair loss.

In some cases, hair loss may be a sign of another underlying condition that requires treatment.

Make an appointment with your doctor

If you’re concerned about hair loss, McMichael recommends making an appointment with your primary care doctor or a board-certified dermatologist.

“A primary care doctor can check for any lab tests that may be related, such as iron profile or thyroid hormone levels. If these labs are normal, recent health effects should be examined,” McMichael said.

“Many women have a common form of hair loss called telogen effluvium,” she continued, “which causes shedding approximately three months after a physiologic stress.”

For example, stress related to childbirth, surgery, severe infection, or other medical issues can contribute to hair loss.

Changes in medications, including oral contraceptives, can also cause hair to thin.

“If it is one of these things, the hair loss will improve on its own in four to six months as long as the cause is stopped or stabilizes,” McMichael said.

If your hair loss has been triggered by something else, a dermatologist may use magnified photography, a hair pull test, or a scalp biopsy to help diagnose the cause.

“It is important to know that many forms of hair loss are treatable,” McMichael said, “and that new treatments are being studied by many investigators.”