Dysmenorrhoea MedDRA version: 12.0 Level: LLT Classification code 10013935 Term: Dysmenorrhoea
Conditions
Interventions
Product Name: VA111913 TS Capsules
Product Code: VA111913 TS Capsules
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral
Sponsors
Vantia Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women between 18 and 35 years old. 2. Negative pregnancy test result. 3. Regular menstrual cycles that are typically between 25 and 35 days and of a fixed length ± 2 days every month. 4. Body mass index (BMI) = 18.5 and = 30 kg/m2 inclusive. 5. History of primary dysmenorrhoea as determined by the following: • Beginning within 4 years of menarche • A consistent history of menstrual pain (prior to or within 1 day of the start of bleeding) that typically requires medication for relief • Menstrual pain leads to some impairment of daily activity (if not treated) • No evidence of other causes of dysmenorrhoea on gynaecological examination either at Screening or documented in the 6 months prior to study entry (start of run in cycle) 6. Negative Papanicolaou (Pap) smear performed either during gynaecological examination at Screening or documented in the 6 months prior to study entry (start of run-in cycle). 7. Has not used hormonal contraceptives within 6 months prior to study entry (start of run-in cycle). 8. In good health as determined by medical history, a screening physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement. 9. Haemoglobin equal to or above the lower limit of normal range or low value not of clinical significance as judged by the investigator. 10. Practising an adequate non hormonal method of contraception (other than intrauterine device) in the opinion of the investigator, is surgically sterilised, is abstinent or has a vasectomised or sterile partner. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosed with secondary dysmenorrhoea (eg, secondary dysmenorrhoea resulting from [but not limited to] the following conditions: endometriosis, adenomyosis, malformations of Müllerian ducts, uterine fibromyomas, ovarian cysts, pelvic varicocoele, inflammatory pelvic disease, adherences, intrauterine devices, cervical stenosis). 2. Has ever undergone gynaecological surgery for pelvic pain or endometriosis (laparoscopy, ovarian surgery, adhesiolysis, myomectomy). 3. Is pregnant, planning pregnancy during the study or in the 60 days thereafter, or is lactating. 4. History of undiagnosed abnormal vaginal bleeding. 5. History of significant drug allergy or significant allergy to multiple allergens, which in the opinion of the investigator could predispose the subject to an allergic reaction to study drugs. 6. Concomitant use of regular prescription or non prescription medications or herbal remedies. 7. Certain medication may be permitted if not given concomitantly with study medication. • Analgesic treatments for conditions other than dysmenorrhoea. Intermittent treatments for such conditions (eg, headache, general body aches, strains) should not be taken within 6 half-lives (or 72 hours, if half-life is unknown) prior to the anticipated start of study medication (Day 2). • Subjects taking analgesia for dysmenorrhoea must stop them for the duration of the study when they will be required to take study medication (plus standardised rescue medication if needed). Note: During a holiday cycle subjects may take their usual treatment for dysmenorrhoea (this must be recorded on the concomitant medication page of the CRF, not as rescue medication). • Use of antihistamines and topically administered steroids will be considered on a subject by subject basis. • Any substance that inhibits cytochrome P450 3A4 (CYP3A4), or is a substrate of CYP3A4 or cytochrome P450 2C9 (CYP2C9) is strictly prohibited. 8. Concomitant use of any device, remedy or alternative therapy used to control pain in dysmenorrhoea (eg, heating pads, transcutaneous electrical nerve stimulation [TENS] or acupuncture) during the study treatment period. (Note: Use of such alternative approaches is permitted during a holiday cycle providing the use is recorded in the CRF.) 9. Any condition or clinically significant abnormal findings on the physical examination, medical history or clinical laboratory results during Screening that, in the opinion of the investigator, would make the subject unsuitable for the study or put her at additional risk. 10. History of peptic ulceration or gastrointestinal bleeding (2 or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation related to previous NSAID therapy. 11. Hypersensitivity to naproxen, naproxen sodium, or any of the excipients. (Since the potential exists for cross sensitivity reactions to naproxen, subjects in whom aspirin or other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, nasal polyps or urticaria should be excluded.) 12. Any clinically significant renal, hepatic or heart failure. 13. Active hepatic and/or biliary disease. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of the normal range; total bilirubin > 1.5 mg/dL (or equivalent). Any other clinical laboratory finding that, in the opinion of the investigator, is clinically significant and prohibits subject participation. 14. Any clinically significant abnorm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of pre-emptive admininistration (prior to the onset of menstrual pain and bleeding) of VA111913 TS Capsules compared to Placebo on reduction of menstrual pain in women with primary dysmenorrhoea. ;Secondary Objective: To investigate the effects of treatment on the need for rescue medication To establish the safety profile of VA111913 TS Capsules To investigate the effect of VA111913 TS Capsules on menstrual bleeding patterns To preliminarily explore the PK/PD relationship of treatment with VA111913 TS Capsules To explore the correlation between trough plasma VA111913 concentration and time-weighted sum of pain intensity (SPI) scores on an 11-point numerical rating scale (NRS) To explore the correlation between trough plasma VA111913 concnetration and the worst pain intensity in the treatment cycle To explore the correlation between luteinising hormone (LH) surge and subjects prediction of onset date of menstruation (based on menstrual history and occurence of usual premenstrual prodromal symptoms) ;Primary end point(s): Time weighted sum of pain intensity (SPI) scores on an 11-point NRS, assessed as the SPI scores for the 24 hours after the onset of bleeding. | — |
Countries
United Kingdom
Outcome results
None listed