Uterine Fibroids (UF)Pink OrchidNCT06058728
A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
An observational study of Uterine Fibroids (UF), run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids (UF)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women 18 to 50 years old with heavy menstrual bleeding (HMB) due to uterine fibroids (UF).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
- Conditions
- Uterine Fibroids (UF)
- Keywords
- Uterine Fibroids (UF), Heavy Menstrual Bleeding (HMB), Oriahnn, Elagolix, Estradiol, Norethindrone Acetate
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Oriahnn Exposure Cohort | Participants prescribed Oriahnn for management of heavy menstrual bleeding (HMB) due to uterine fibroids (UF). | |
| Part 2 - Nested Hair Loss Cohort | Participants prescribed Oriahnn for management of HMB due to UF, with meaningful hair loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Meaningful Hair Loss
Meaningful hair loss is defined as patient-reported 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.
Measured: Up to Month 24
Time to Onset of Hair Loss
Time from initiation of Oriahnn until patient-reported meaningful hair loss will be assessed.
Measured: Up to Month 42
Changes in Patterns of Hair Loss
Based on example description and images of alopecia subtypes, changes in patterns of hair loss are classified as primary pattern of hair loss.
Measured: Up to Month 42
Number of Participants with Improvement in Hair Loss
Defined as a report that since the participant has reported hair loss, her hair loss has improved.
Measured: Up to Month 42
Number of Participants with Resolution in Hair Loss
Resolution in hair loss is defined as a report that since the patient has reported hair loss, her hair has returned to normal.
Measured: Up to Month 42
Time to Resolution in Hair Loss
Time from onset of meaningful hair loss until reported resolution.
Measured: Up to Month 42
Number of Participants who Discontinued Oriahnn at Reported Hair Loss
Discontinuations of Oriahnn at or after reported hair loss will be calculated.
Measured: Up to Month 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Dec 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids (UF)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058728
- Sponsor's protocol ID
- P20-400
- Acronym
- Pink Orchid
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06058728
- Acronym / sponsor ID
- Pink Orchid / P20-400
- Conditions
- Uterine Fibroids (UF)
- Keywords
- Uterine Fibroids (UF), Heavy Menstrual Bleeding (HMB), Oriahnn, Elagolix, Estradiol, Norethindrone Acetate
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Oriahnn Exposure Cohort | – | –Participants prescribed Oriahnn for management of heavy menstrual bleeding (HMB) due to uterine fibroids (UF). |
| Part 2 - Nested Hair Loss Cohort | – | –Participants prescribed Oriahnn for management of HMB due to UF, with meaningful hair loss. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women 18 to 50 years old with heavy menstrual bleeding (HMB) due to uterine fibroids (UF).
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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.
- Initiation or changes in medications or doses for the management of thyroid diseases
- Any other medical condition or surgery requiring hospitalization (other than UF)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants with Meaningful Hair Loss
Time frame: Up to Month 24
Meaningful hair loss is defined as patient-reported 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.
Time to Onset of Hair Loss
Time frame: Up to Month 42
Time from initiation of Oriahnn until patient-reported meaningful hair loss will be assessed.
Changes in Patterns of Hair Loss
Time frame: Up to Month 42
Based on example description and images of alopecia subtypes, changes in patterns of hair loss are classified as primary pattern of hair loss.
Number of Participants with Improvement in Hair Loss
Time frame: Up to Month 42
Defined as a report that since the participant has reported hair loss, her hair loss has improved.
Number of Participants with Resolution in Hair Loss
Time frame: Up to Month 42
Resolution in hair loss is defined as a report that since the patient has reported hair loss, her hair has returned to normal.
Time to Resolution in Hair Loss
Time frame: Up to Month 42
Time from onset of meaningful hair loss until reported resolution.
Number of Participants who Discontinued Oriahnn at Reported Hair Loss
Time frame: Up to Month 42
Discontinuations of Oriahnn at or after reported hair loss will be calculated.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids (UF), run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Meaningful Hair Loss (time frame: Up to Month 24). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.