Ended Therapeutic confirmatory (Phase III) Prevention of pregnancy

A multicentre, single arm trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 13 cycles.

EU CTIS ID: 2022-502023-21-00

What this study is testing

To demonstrate the contraceptive efficacy of LVDS.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

[Visit 1a:] Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
[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 (not applicable to adolescents).
[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:] Only for female subjects between the ages of 15 and 17 (inclusive) provided that: a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. c. All special radiation protection approval requirements have been confirmed by corresponding official approvals and the sponsor has authorised the recruitment of underage participants in writing to the trial site. (Adolescents will not be included in Czech Republic and Germany)
[Visit 1a:] Women who either a. have never used hormonal contraceptives before consent/assent (naïve users), or b. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent 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/assent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.

You likely can't join if

[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 / 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).

See the full eligibility criteria

Who can join

[Visit 1a:] Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
[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 (not applicable to adolescents).
[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:] Only for female subjects between the ages of 15 and 17 (inclusive) provided that: a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. c. All special radiation protection approval requirements have been confirmed by corresponding official approvals and the sponsor has authorised the recruitment of underage participants in writing to the trial site. (Adolescents will not be included in Czech Republic and Germany)
[Visit 1a:] Women who either a. have never used hormonal contraceptives before consent/assent (naïve users), or b. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent 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/assent: 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/assent: 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/assent is available, prior to undergoing any trial-related procedure.
[Visit 1a:] Willing to use trial contraception for thirteen 28-day cycles.
[Visit 1a:] Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive (not applicable to adolescents).

What rules you out

[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 / 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 / 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:] 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: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] History of low trauma fracture(s) defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face and skull.
[Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Known medical conditions associated with low bone mass: a. Metabolic bone disease such as osteogenesis imperfecta, Paget’s disease of the bone, osteomalacia/rickets b. Rheumatoid arthritis c. Collagen vascular diseases such as Marfan’s syndrome and Erhlos-Danlos syndrome d. Chronic kidney disease e. Hyperparathyroidism and abnormal bone mineral metabolism (hypocalcemia/ hypercalcemia, hypophosphatemia/ hyperphosphatemia, hypomagnesemia).
[Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium.
[Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Treatment with medications that are known to decrease bone mass: a. Glucocorticoids (oral, intravenous, chronic inhaled, chronic extensive topical) within the previous 3 months. Oral/intravenous glucocorticoids (prednisone ≥ 2.5 mg daily for ≥ 3 months, or the equivalent) within the last 12 months. b. Depo-medroxyprogesterone acetate within the previous 24 months. Depo-medroxyprogesterone acetate for a duration of use greater than 2 years ever in life. c. Aromatase inhibitors and/or raloxifene within the previous 24 months. d. Heparin, warfarin, thiazolidinedione, SGLT-2 inhibitors, tricyclic antidepressants, chronic proton pump inhibitor (PPI) use, selective serotonin reuptake inhibitors (SSRIs) within the previous 3 months.
[Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Conditions that preclude BMD measurement i.e. lumbar spine/bilateral hip surgery with hardware in place, abdominal clips, umbilical ring (not willing to remove) or weight that exceeds the DXA machine limitation.
[Visit 1b: Additional exclusion criterion for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] BMD Z-score below -1.5.
[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 amenorrhoea.
[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 or to any of the excipients.
[Visit 1a:] Uncontrolled concomitant chronic diseases (i.e., not on a stable treatment dose for at least 2 months at the time of assent/consent).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 0-17 years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.