A pivotal, multicentre, randomised, open-label, parallel-group trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 9 cycles in comparison with Desogestrel tablets 0.075 mg.

Phase 1

Conditions: Prevention of pregnancy
MedDRA version: 20.0Level: PTClassification code: 10010808Term: Contraception Class: 100000004865
Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Registration Number: CTIS2022-502024-51-00

Lead Sponsor: Chemo Research S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 1356

Inclusion Criteria

[Visit 1a:] Sexually active, postmenarcheal and premenopausal female subjects = 18 years at risk of pregnancy including breastfeeding women., [Visit 1a:] Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed)., [Visit 1a:] Women who either a. have never used hormonal contraceptives before consent (naïve users), or b. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent and a full menstrual cycle during the drug-free period (previous users) or c. directly switch from another hormonal contraceptive (switchers)., [Visit 1a:] Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months., [Visit 1a:] Only for women who were pregnant within the last 6 months before consent: At least 3 complete menstrual cycles after pregnancy. Breastfeeding women can be included 4 weeks after delivery irrespective of menstrual cycles post-delivery., [Visit 1a:] Systolic blood pressure = 140 mm Hg and diastolic blood pressure = 90 mm Hg, subjects with controlled hypertension are allowed., [Visit 1a:] A written informed consent is available, prior to undergoing any trial-related procedure., [Visit 1a:] Willing to use the trial contraception they were randomised to (vaginal ring or oral tablet) for nine 28-day cycles., [Visit 1a:] Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive., [Visit 1a:] Be willing to state that, to her best knowledge, her male sexual partner/partners has/have not had a vasectomy or been previously diagnosed as infertile.

Exclusion Criteria

[Visit 1a / Visit 1b:] Pregnancy or wish of pregnancy., [Visit 1a:] Severe COVID-19 disease or less than 3 months after hospitalization due to a COVID-19 disease., [Visit 1a:] Known HIV infection., [Visit 1a:] Known current or chronic hepatitis B or C., [Visit 1a:] Gastrointestinal (malabsorptive) disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis), gastric bypass surgery, current post gastrectomy syndrome and celiac disease., [Visit 1a / Visit 1b:] Prohibited previous medication/therapy (as given in the protocol), [Visit 1a / Visit 1b:] Dependence on prohibited co-medication/-therapy (as given in the protocol), [Visit 1a / Visit 1b:] Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last 2 months., [Visit 1a:] Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures., [Visit 1a:] Subject is a member of the investigator’s or sponsor’s staff or a relative or family member thereof., [Visit 1a:] Is in custody or submitted to an institution by a court order., [Visit 1a:] Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary., [Visit 1a / Visit 1b:] Any condition or any disease that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial., [Visit 1a:] History of infertility., [Visit 1a:] Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a., [Visit 1a:] Unexplained amenorrhea., [Visit 1a:] Abnormal finding on pelvic, breast or ultrasound examination that in the investigator’s opinion contraindicates participation in the trial., [Visit 1a:] Women - with a Papanicolaou (Pap) smear reading low-grade squamous intraepithelial lesion (LGSIL) or higher at screening. Subjects with atypical squamous cells of undetermined significance (ASC-US) can be included if they are negative for high-risk human papilloma virus (HPV) strains., [Visit 1a:] Known contraindication including: a. Active venous thromboembolic disorder and/or a VTE history including a known positive family history in a sibling or parent. b. Arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease). c. Major surgery with prolonged immobilisation. d. Diabetes mellitus with vascular involvement. e. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. f. Presence or history of liver tumours (benign or malignant). g. Known severe renal insufficiency or acute renal failure. h. Known adrenal insufficiency. i. Known or suspected sex steroid sensitive malignancies, including breast cancer. j. Hypersensitivity to the active substance, soya, peanut or to any of the excipients. k. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption., [Visit 1a:] Uncontrolled concomitant chronic diseases (i.e., not on a stable treatment dose for at least 2 months at the time of consent).