Ongoing Clinical Trials for Dysmenorrhoea
There are currently 2 ongoing clinical trials investigating new treatment approaches for dysmenorrhoea, commonly known as painful menstrual periods. These studies are being conducted across multiple countries in Europe and are testing different interventions, including botulinum toxin injections and herbal extract treatments, for women who experience severe menstrual pain.
Clinical trial locations
- Austria
- Czechia
- France
- Germany
- Hungary
- Poland
- Sweden
Evaluation of Botulinum Toxin Injections for Women with Severe Primary Dysmenorrhea Unresponsive to First-Line Treatments
This trial is investigating an innovative treatment approach for women who experience extremely painful menstrual periods that have not improved with standard treatments. The study focuses on using botulinum toxin injections delivered directly into the muscle layer of the uterus through a procedure called hysteroscopy.
Main inclusion criteria: Women eligible for this study must be adults who have not reached menopause and suffer from severe menstrual pain, with an average pain score of 6 or higher out of 10 over the past three months. Importantly, participants must have already tried standard medical treatments without success, including hormonal therapy and pain medications such as NSAIDs. A recent pelvic MRI within the last six months must show no evidence of endometriosis, endometriosis cysts, or uterine fibroids. All participants must use highly effective birth control methods, including hormonal contraception, IUDs, condoms, or other methods with less than 1% failure rate, and have a negative pregnancy test before joining the study.
Main exclusion criteria: Women cannot participate if they have had previous uterine surgery, have unexplained abnormal uterine bleeding, have blockages in the uterus such as fibroids or polyps, or have adenomyosis. The study also excludes women who are pregnant, planning pregnancy, or breastfeeding. Those with allergies to botulinum toxin, neuromuscular diseases like myasthenia gravis, active pelvic infections, or those who have never had sexual intercourse cannot participate. Women who cannot understand or follow study instructions or who have participated in another clinical trial within the past three months are also excluded.
Focus and goal: This is a double-blind, randomized controlled trial, meaning neither participants nor researchers know who receives the actual treatment versus placebo injections. The main goal is to evaluate whether botulinum toxin injections can significantly reduce menstrual pain in women who haven’t responded to first-line treatments. Participants will be followed for six months, with assessments at one, three, and six months after the procedure. The study measures changes in menstrual pain intensity, pain during sexual intercourse, sexual function, quality of life, and other related symptoms through various questionnaires. The primary assessment occurs at three months to determine meaningful symptom improvement.
Investigational drug: The trial uses botulinum toxin, which works by blocking nerve signals and muscle contractions. In this study, it’s injected into the myometrium, the middle layer of the uterine wall, to potentially reduce the painful uterine contractions associated with menstruation. This represents a novel approach to managing severe menstrual pain by directly targeting the uterine muscle rather than using systemic medications.
Study on the Effectiveness of Chaste Tree Extract (Vitex agnus-castus BNO 1095) for Women with Menstrual Cramps (Primary Dysmenorrhea)
This clinical trial is studying a herbal medicine derived from chaste tree fruit to determine if it can help reduce symptoms of painful menstrual cramps. The study tests Vitex agnus-castus BNO 1095 over the course of three menstrual cycles.
Main inclusion criteria: Women aged 18 to 49 years who have been diagnosed with primary dysmenorrhea and are able to give informed consent can participate. Participants must have regular menstrual cycles lasting between 24 to 38 days. If they currently take pain relief medication for menstrual cramps, they should continue using the same type and strength of medication as before the trial. All participants must agree to use contraception during the study, including options such as tubal occlusion, having a partner with vasectomy, sexual abstinence, condoms with or without spermicide, or caps, diaphragms, or sponges with spermicide.
Main exclusion criteria: Women who are not experiencing primary dysmenorrhea cannot participate. Men are excluded from this study. Individuals outside the specified age range of 18 to 49 years and those considered part of vulnerable populations who may have limited ability to give informed consent or are at higher risk of harm are also excluded.
Focus and goal: Participants are randomly assigned to receive either the Vitex agnus-castus BNO 1095 treatment or a placebo. The study monitors symptoms over three menstrual cycles to evaluate whether there is improvement in cramping pain. The primary goal is to observe a reduction of at least 3 points in the peak pelvic pain score during the final menstrual cycle compared to baseline, with no increase in the use of standard pain relief medication. This trial aims to provide valuable information on whether this herbal medicine can be an effective option for managing menstrual pain.
Investigational drug: The trial uses Vitex agnus-castus BNO 1095, a herbal medication administered as a 20 mg oral tablet. This supplement is believed to work by influencing hormone levels, particularly by modulating the balance of estrogen and progesterone, which may help reduce menstrual pain. It represents a natural treatment approach for women seeking alternatives for managing menstrual-related symptoms.
Summary
The two ongoing clinical trials for dysmenorrhoea represent distinctly different treatment approaches. One trial, conducted in France, focuses on an interventional medical procedure using botulinum toxin injections specifically for women with severe symptoms who have not responded to standard treatments. The other trial, conducted across six countries including Hungary, Czechia, Germany, Poland, Sweden, and Austria, investigates a herbal medicine option that may appeal to women seeking more natural treatment alternatives.
The broader geographic distribution of the herbal extract trial suggests wider accessibility for European patients, while the botulinum toxin trial represents a more specialized intervention for severe cases. Both studies use rigorous double-blind, placebo-controlled designs to ensure reliable results. These trials highlight the ongoing efforts to provide women with different treatment options depending on the severity of their symptoms and their treatment preferences.