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Hair loss side effect under scrutiny in fibroid drug study

NCT ID NCT06058728

Knowledge-focused Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study was designed to track hair loss in women with uterine fibroids who are taking the medication Oriahnn. Researchers planned to follow about 1,600 women for up to 24 months, using questionnaires and scalp photos to see how common hair loss is, when it starts, and if it goes away. However, the study was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oriahnn (elagolix with estradiol and norethindrone acetate)
What this could lead to
If successful, this study could help doctors better understand and manage hair loss as a side effect of Oriahnn in women with uterine fibroids.
What could go wrong
This is an observational study with no control group, so it cannot prove cause and effect. It was also withdrawn before enrolling any participants, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Started

Dec 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women 18 to 50 years old with heavy menstrual bleeding (HMB) due to uterine fibroids (UF).

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Part 1: * International Classification of Disease-10 (ICD-10) diagnosis codes for both uterine fibroids (UF) (D25.X) and heavy menstrual bleeding (HMB), defined as menorrhagia (N92.0, N92.4) or menometrorrhagia (N92.1) in the electronic health record (EHR) system. * Plans to initiate or has initiated Oriahnn treatment within 14 days of study enrollment. * Able to provide photographs of their scalp within 14 days of Oriahnn initiation, based on instruction provided. Part 2: \- Changes in thickness, fullness or pattern of hair that results in less hair than normal, or hair shedding that is increased from normal in the Hair Questionnaire. Exclusion Criteria: * Current or history of hair thinning, hair loss, or alopecia (defined as physician-diagnosed or patient-reported hair loss). * Have a contraindication to receive Oriahnn per Prescribing Information. * Any of the following occurrences within 180 days prior to Oriahnn prescription. * Prescription for Oriahnn, another gonadotropin releasing hormone (GnRH) antagonist \[including Myfembree (relugolix, estradiol/norethindrone acetate\]) or GnRH agonist. * Pregnancy/Childbirth. * New diagnosis of thyroid disease. * New diagnosis of inflammation or infection of the scalp (e.g., psoriasis, tinea capitis). * Have taken medications or undergone therapies that may cause alopecia, hair loss, or both. This includes but is not limited to chemotherapy, checkpoint inhibitors, epidermal growth factor antagonists, or radiation anywhere on the body. * Initiation or changes in medications or doses for the management of thyroid diseases * Any other medical condition or surgery requiring hospitalization (other than UF)

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Conditions

The condition(s) this trial relates to.

leiomyoma Menorrhagia uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uterine fibroids (UF)

Contacts and locations

Locations

  • Dorsata /ID# 252675

    Arlington, Virginia, 22201-5330, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.