Study to investigate the efficacy of chaste tree (Vitex agnus-castus BNO 1095 (20 mg)) in women with cramping pain in the lower abdomen occurring just before or during menstruation (primary dysmenorrhea)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bionorica SE

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

28 Nov 2023 → 23 Jul 2025

Decision date (initial)

2023-11-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bionorica SE

External identifiers

EU CT number

2023-503688-41-00

WHO UTN

U1111-1288-9484

ClinicalTrials.gov

NCT06211049

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To determine if primary dysmenorrhea improves in women treated with Vitex agnus-castus BNO 1095 20 mg compared to placebo over a treatment duration of 3 menstrual cycles (cramping windows of Cycles 3-5).

Conditions and MedDRA coding

Primary Dysmenorrhea

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Women aged 18-49 years who have the capacity for consenting
2. Patient has been informed of the nature, scope, and relevance of the clinical trial, voluntary agrees in participation and the trial provisions, and has duly signed the approved informed consent form (ICF)
3. Diagnosed primary dysmenorrhea (see Section 5.1, Table 1)
4. If patients take pain relief medication for primary dysmenorrhea, this medication should be taken unchanged with regard to application form and kind of medication including strength … [due to commercially confidential information restrictions]. Note: Medication (drugs) for primary dysmenorrhea as mono- or combination therapy in form of tablets/capsules regularly used by the patient before Screening is allowed to be used as standard pain relief medication during the trial apart from non-medication methods. A complete list of allowed pain relief medication is attached to the protocol (Appendix 2). … [due to commercially confidential information restrictions].
5. Patients with a regular menstrual cycle duration of ≥24 to ≤38 days
6. Patients agreeing to use one of the following contraception methods throughout the trial: a. Bilateral tubal occlusion b. Vasectomized partner (provided that the partner is the sole sexual partner of the woman and has received medical assessment of the surgical success) c. Sexual abstinence Abstinence is only accepted as true abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal) is not an acceptable method of contraception. d. Male or female condom with or without spermicide e. Cap, diaphragm, or sponge with spermicide.

Exclusion criteria 25

1. Non-menstruating women
2. Clinically diagnosed secondary dysmenorrhea (e.g., fibroids, uterine adenomyosis, endometriosis, pelvic inflammation, ovarian pathologies, or other pelvic diseases)
3. Dysmenorrhea resulting from the use of an intrauterine device.
4. Use of hormonal contraceptives (oral, intravaginal, transdermal, injectable, implantable), intrauterine device, or intrauterine hormone-releasing system within 6 months prior to the trial and not willing to waive it during the entire trial period.
5. Any surgical treatments in the past (e.g., due to myoma) that may cause pain, adhesions or scarring in the lower abdomen Note: Further diagnostic examination (e.g., laparoscopy for differential diagnosis, exclusion of endometriosis) if deemed necessary by the investigator will be outside the trial protocol and reimbursement.
6. Known or suspected gastrointestinal or urological conditions that may cause abdominal and/or pelvic pain, such as colitis, appendicitis, irritable bowel syndrome, cholelithiasis, interstitial cystitis, cystitis, urolithiasis, and other conditions that, according to the investigator’s judgement, are not suitable for the trial.
7. Known or suspected gynecological complaints e.g., premenstrual abdominal pain, deep dyspareunia, uterine fibroids and polyps, or chronic pain (abdominal, dorsal, urogenital).
8. Known instable diseases e.g., psychiatric, cardiovascular, or endocrine disorders.
9. Body mass index <18.5 or >34.9 kg/m² at Screening.
10. Known or suspected acute infection of gonorrhea, syphilis and/or chlamydia at Screening
11. Current or past estrogen sensitive cancer or pituitary disorder that, in the investigator’s opinion, would make the patient not suitable for the trial.
12. Women who are breastfeeding, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the trial.
13. Fewer than 3 menstrual cycles before Screening following delivery, abortion, miscarriage, or lactation.
14. Current severe physical or mental illness.
15. Patient does not agree to avoid daily smoking.
16. History of alcohol, drug, or medicine abuse within 1 year prior to Screening, or positive for drugs or medicines of abuse in the laboratory analysis performed at Screening.
17. Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
18. Hypersensitivity to Vitex agnus-castus, lactose or any of the excipients of the IMP or to any ingredients of the standard pain relief medication.
19. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
20. Employees of the sponsor or site staff or direct relatives of the site staff.
21. Legal incapacity or limited legal capacity.
22. Patients not able to follow trial instructions or assessments or to participate in the trial … [due to commercially confidential information restrictions] or unable to understand written and verbal instruction, in particular regarding the risks and inconveniences that the patients will be exposed to during participation in the clinical trial.
23. Participation in another interventional clinical trial during the last month before Screening.
24. Use of Vitex agnus-castus containing preparation or product within the last 3 months before Screening.
25. Current intake or intake within the last 4 weeks before Screening of dopamine agonists, dopamine antagonists, estrogens, or antiestrogens that would make the patient not suitable for the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score assessed in the cramping window of Cycle 5 compared to Baseline AND b) no increase in the number of standard pain relief medication taken in the cramping window of Cycle 5 compared to Baseline.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bionorica SE

Sponsor organisation

Bionorica SE

Address

Kerschensteinerstrasse 11-15

City

Neumarkt I.D.Opf.

Postcode

92318

Country

Germany

Scientific contact point

Organisation

Bionorica SE

Contact name

Kundeninfoservice

Public contact point

Organisation

Bionorica SE

Contact name

Kundeninfoservice

Third parties 10

Locations

6 EU/EEA countries · 38 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 114 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications