Clinical trial NCT06058728: A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Official title: A Prospective, Single-Arm, Descriptive Observational Study to Evaluate Changes in Hair in Women Exposed to Oriahnn® (Elagolix 300 mg BID With Estradiol 1 mg/Norethindrone Acetate 0.5 mg QD)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Uterine Fibroids (UF)
Keywords: Uterine Fibroids (UF)
Heavy Menstrual Bleeding (HMB)
Oriahnn
Elagolix
Estradiol
Norethindrone Acetate
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 18 to 50 years old with heavy menstrual bleeding (HMB) due to uterine fibroids (UF).

Brief summary: Uterine Fibroids (UF) are benign smooth muscle neoplasms of the uterus that affect women of reproductive age. UFs are one of the leading causes of hospitalizations for gynecological disorders and often lead to hysterectomy. In this study, women with heavy menstrual bleeding (HMB) due to UF who are being treated with Oriahnn will be followed to establish the incidence rate, time to onset, extent, pattern, and resolution of meaningful hair loss, as well as any racial differences.

Oriahnn is an approved drug for the management of HMB associated with UF. All study participants will receive Oriahnn as prescribed by their study doctor in accordance with approved local label. Study Participants will be followed for up 24 months (part 1). Approximately 1600 participants aged 18-50 years will be enrolled at 1 site in the United States.

Participants will receive oral Oriahnn as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 24 months.

There is expected to be no additional burden for participants in this trial. Participants will complete questionnaires on a quarterly basis.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants with Meaningful Hair Loss
timeFrame: Up to Month 24
measure: Time to Onset of Hair Loss
timeFrame: Up to Month 42
measure: Changes in Patterns of Hair Loss
timeFrame: Up to Month 42
measure: Number of Participants with Improvement in Hair Loss
timeFrame: Up to Month 42
measure: Number of Participants with Resolution in Hair Loss
timeFrame: Up to Month 42
measure: Time to Resolution in Hair Loss
timeFrame: Up to Month 42
measure: Number of Participants who Discontinued Oriahnn at Reported Hair Loss
timeFrame: Up to Month 42
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Dorsata /ID# 252675
state: Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: