Portland, ORNCT07235917Now EnrollingIRB Ready

Functional Hypothalamic Amenorrhea (FHA) Clinical Trial in Portland, OR

Access cutting-edge functional hypothalamic amenorrhea (fha) treatment through this clinical trial at a research site in Portland. Study-provided care at no cost to qualified participants.

Sponsored by Regeneron Pharmaceuticals

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Expert Care in Portland

Access functional hypothalamic amenorrhea (fha) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related functional hypothalamic amenorrhea (fha) treatment provided free

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Check if you qualify for this functional hypothalamic amenorrhea (fha) clinical trial in Portland, OR

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Why Participate?

  • No-Cost Study Care

  • Local to Portland

    Convenient for OR residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Portland site if eligible
  4. 4Begin participation

About This Functional Hypothalamic Amenorrhea (FHA) Study in Portland

This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on patients with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly. The aim of the study is to see how well the study drug helps the body make the hormones necessary for ovulation and reproduction, and to assess its safety. The study is looking at several other research questions, including: * Whether the drug helps bone health * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Sponsor: Regeneron Pharmaceuticals

Who Can Participate

Inclusion Criteria

Diagnosis of FHA after

Exclusion Criteria

of anatomic or organic causes of amenorrhea
Has had no menstrual bleeding episode within 3 months (or longer) prior to day 1, as described in the protocol
Has a Body Mass Index (BMI) ≥18.5 and \<25 kg/m\^2 at screening, or BMI ≥25 to \<30 kg/m\^2 at screening AND percentage of body fat \<20% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening, as described in the protocol Key Exclusion Criteria:
Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle)
Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening
Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian (eg, absence of an ovary, presence of polycystic ovaries) conditions that impact assessment of menses or of the HPO axis
Has conditions other than FHA that may cause amenorrhea or menstrual cycle disturbances (eg, polycystic ovarian syndrome, hyperprolactinemia, primary ovarian insufficiency, untreated primary hypothyroidism, primary hyperthyroidism)
Polycystic ovarian morphology with an ovarian volume \>10 cc on TransVaginal UltraSound (TVUS) \[or TransAbdominal Pelvic Ultrasound (TAPU) if applicable\] at baseline
Presence of follicle ≥17 mm, evidence of ruptured follicle, and/or evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline NOTE: Other protocol-defined Inclusion/Exclusion criteria apply

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Portland?

Yes, this clinical trial (NCT07235917) has an active research site in Portland, OR that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Functional Hypothalamic Amenorrhea (FHA) Treatment Options in Portland, OR

If you're searching for functional hypothalamic amenorrhea (fha) treatment options in Portland, OR, this clinical trial (NCT07235917) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Portland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced functional hypothalamic amenorrhea (fha) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all functional hypothalamic amenorrhea (fha) clinical trials near you to find additional studies recruiting in your area.

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