A Phase 4 interventional study of Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health and Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health in Endometriosis, Endometriosis and Dysmenorrhea and Endometriosis (Diagnosis), sponsored by Colorado State University. Not yet recruiting. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Colorado State University · Phase 4, Interventional, and Basic science
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis.
This research study wants to understand how medications used to treatment symptoms of endometriosis impact brain health in patients with endometriosis. To learn about this, eligible participants with endometriosis will undergo a baseline blood draw and magnetic resonance imaging (MRI) scan. Then, they will be randomly assigned to receive one of three medications. The three medications used in this study are common medications that patients may receive to manage their symptoms of endometriosis. This means that they are medically approved for the treatment of endometriosis symptoms. Participants will complete the blood draw and MRI scan again after \~28 days of treatment.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's planned enrollment of 45 is below the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additional drug related exclusion criteria: We will additionally exclude for the following reasons as related to safety or contraindications for study medications:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 mg norethindrone acetate pill, taken daily for \~28 days, approved to treat symptoms of endometriosis.
Drug: Investigate how norethindrone acetate, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
Oral gonadotropin releasing antagonist, taken daily for \~28 days, approved for the treatment of moderate-to-severe endometriosis symptoms
Drug: Investigate how Orlissa, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
Oral gonadotropin releasing antagonist, taken daily for \~28 days, with estrogen and progestin add-back.
Drug: Investigate how Oriahnn, a commonly used medication used to treat symptoms of endometriosis, impact biomarkers of brain health
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Also known as: norethindrone acetate
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Also known as: Orlissa
Eligible participants will prospectively be randomized to one of three medications approved for the treatment of endometriosis symptoms.
Also known as: Oriahnn
Cerebral blood flow
Cerebral blood flow measured via Arterial Spin Labeling Magnetic Resonance Imaging
Time frame: Baseline and ~28 days
Neuroinflammation
Plasma biomarker of astrocyte activation and neuroinflammation via glial fibrillary acidic protein \[GFAP\]
Time frame: Baseline and ~28-days
Neuronal microstructure
Grey and white matter neuronal microstructure
Time frame: Baseline and ~28 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2029, 30 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Norethindrone Acetate · Elagolix