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New treatment option for Autoimmune Prematur Ovarian Insuffience
Official title Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency
ClinicalTrials.gov ID: NCT07509840
What this study is testing
What is Rituximab (Arm A)?
Rituximab (Arm A) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune prematur ovarian insuffience.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Several autoimmune diseases such as Addison's disease are associated with failing ovarian function, known as premature ovarian insufficiency (POI), which can lead to early menopause and reduced fertility.The underlying cause of POI in these women is considered to be an immunological attack on the ovaries that causes them to not respond to hormonal stimulation from the brain. Hormone replacement effectively counteracts menopausal symptoms, but today there is no treatment to normalize or even improve fertility.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 38, women only
You may be able to join if
- The subject has given their written consent to participate in the trial
- Autoimmune POI (FSH \> 25 IU/L) including the presence of oligo/amenorrhea lasting at least 4 months, and elevated FSH levels (FSH \> 25 IU/L)...
- 18-38 years of age
- Body mass index between 19-30
- Willing to use effective non-hormonal contraceptive (such as intra uterine device (IUD), sexual abstinence, male or female condom with or without...
You likely can't join if
- Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)
- Active, severe infection or JCV positivity
- Active hepatitis B infection
- Severe immunosuppression
- Severe cardiac disease
- Cancer
See the full eligibility criteria
- The subject has given their written consent to participate in the trial
- Autoimmune POI (FSH \> 25 IU/L) including the presence of oligo/amenorrhea lasting at least 4 months, and elevated FSH levels (FSH \> 25 IU/L) confirmed on two separate occasions, with measurements taken at least 4...
- 18-38 years of age
- Body mass index between 19-30
- Willing to use effective non-hormonal contraceptive (such as intra uterine device (IUD), sexual abstinence, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) method during the...
- Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)
- Active, severe infection or JCV positivity
- Active hepatitis B infection
- Severe immunosuppression
- Severe cardiac disease
- Cancer
- Benign tumours of the hypothalamus, pituitary, or ovarian pathology
- Vaginal bleeding of unknown etiology
- Hormone replacement therapy within four weeks prior study entry
- Pregnant or lactating women
- Concurrent treatment with other immunosuppressive drugs
- Any vaccination within 4 weeks of infusion of study medication
- Severe psychiatric disorder
- Any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with rituximab or controlled ovarian hyperstimulation
- Active thrombolic disorder (contraindicated for Ovirelle)
- Moderate or severe impairment of kidney or liver function (contraindicated for Orgalutran) \-
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 38 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.