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Tests treatment safety and results for Primary Dysmenorrhea
Official title Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea
ClinicalTrials.gov ID: NCT05640232
What this study is testing
What is CDE100 association?
CDE100 association is an investigational medicine, being studied as a potential treatment for primary dysmenorrhea.
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
- The purpose of this study if to evaluate the efficacy and safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 35, women only
You may be able to join if
- Patient has given written informed consent to participate in the study prior to admission to the study;
- Female patients aged between 16 and 35 years old, inclusive;
- History of regular menstrual cycles, occuring between every 21 to 35 days;
- Clinical history compatible with the diagnosis of primary dysmenorrhea;
- Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study.
You likely can't join if
- Diagnosis of secondary dysmenorrhea;
- History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps;
- Onset of primary dysmenorrhea after starting to use oral contraceptives;
- Use of oral contraceptives for \< 3 months prior to study selection;
- Use of an intrauterine device (IUD), hormonal implants or contraceptive injections in the last six (06) months;
- Previous diagnosis or physical examination findings and/or clinical and/or surgical history that may indicate the presence of endometriosis, pelvic...
See the full eligibility criteria
- Patient has given written informed consent to participate in the study prior to admission to the study;
- Female patients aged between 16 and 35 years old, inclusive;
- History of regular menstrual cycles, occuring between every 21 to 35 days;
- Clinical history compatible with the diagnosis of primary dysmenorrhea;
- Self-reported history of ≥ 4 painful cycles, with moderate or severe menstrual cramps, in the six (06) months prior to selection for the study.
- Diagnosis of secondary dysmenorrhea;
- History of non-response to treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to relieve menstrual cramps;
- Onset of primary dysmenorrhea after starting to use oral contraceptives;
- Use of oral contraceptives for \< 3 months prior to study selection;
- Use of an intrauterine device (IUD), hormonal implants or contraceptive injections in the last six (06) months;
- Previous diagnosis or physical examination findings and/or clinical and/or surgical history that may indicate the presence of endometriosis, pelvic inflammatory disease, adenomyosis, mullerian duct malformation, uterine...
- History of recurrent pelvic and/or lower abdominal pain outside the menstrual period;
- Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;
- History of hypersensitivity reactions, such as asthma attacks or other types of allergic reactions, to acetylsalicylic acid or other NSAIDs;
- History or diagnosis of peptic/hemorrhagic ulcer;
- History of gastrointestinal bleeding or perforation related to the use of NSAIDs;
- Presence of compromised bone marrow function or diseases of the hematopoietic system;
- Diagnosis of acute intermittent hepatic porphyria;
- Diagnosis of congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD);
- Diagnosis of untreated angle-closure glaucoma;
- Presence of mechanical stenosis in the gastrointestinal tract;
- Diagnosis of megacolon and/or paralytic or obstructive ileus;
- Diagnosis of myasthenia gravis;
- Treatment with psychoactive drugs (such as, for example, antidepressants, antipsychotics, etc.) in the 30 days prior to selection for the study;
- Participants with a history of alcohol or illicit drug use disorder in the last two (02) years;
- Participants with a current medical history of cancer and/or cancer treatment in the last five (05) years;
- Presence of any serious illness, at the discretion of the investigator;
- Any finding of clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical...
- Participants who are pregnant, nursing or planning to become pregnant;
- Disagreement with the use of a known effective barrier contraceptive method, unless using a stable oral contraceptive for three months or more (which must be maintained throughout the study), or surgically sterile or...
- Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it;
- Presence of any condition that, at the discretion of the investigator, makes the patient unfit to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hortolândia, São Paulo, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 16 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hortolândia, São Paulo, Brazil. 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.