A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles

Completed · Phase 3 · Has a placebo group

Conditions studied: Contraception

In brief

The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.

Key facts

Study ID: NCT03945513
Run by: Insud Pharma
People needed: 1034
Starts: 2019-12-03
Expected to finish: 2023-09-08
Last updated by the study team: 2023-11-14

Who can join

Age: 13 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy aged between 13-45 years (inclusive) (at the time of trial enrollment).
Female subjects at risk of pregnancy aged between 13 and 17 years (inclusive) provided that:
Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services,
All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
Women who:
have never used hormonal contraceptives before consent/assent (naïve users),
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)
directly switch from another hormonal contraceptive (switchers).
Only for subjects who did not use hormonal contraception during the last six months before consent/assent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months.
At least three complete menstrual cycles after delivery pregnancy (only applicable for women who were pregnant within the last six months).
At screening, maximum systolic blood pressure ≤ 140 mm Hg and diastolic blood pressure ≤ 90 mm Hg.
Be able and willing to provide written informed consent or assent if the subject is adolescent, prior to undergoing any trial-related procedure.
Willing to use trial contraception for thirteen 28-day cycles.
Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive.
Be willing to state that, to her best knowledge, her male sexual partner(s):
Has not had a vasectomy or been previously diagnosed as infertile.
Has not been previously diagnosed or suspected of human immunodeficiency virus (HIV) unless he has subsequently had a negative HIV test.
Has not been known to have engaged in homosexual intercourse in the past five years unless he has had negative HIV test results since then.
Has not shared injection drug needles in the past unless he has had a negative HIV test at least six weeks since last use.
Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed).

You may not qualify if…

Pregnancy, wish for pregnancy, or breastfeeding subjects.
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.
History of infertility.
Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
Unexplained amenorrhea.
Known polycystic ovary syndrome (PCOS).
Women ≥21 years of age with a Papanicolaou (pap) smear reading low-grade squamous intraepithelial lesion (LGSIL) or higher at screening (or six months prior to screening date). 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. Subjects <21 years of age do not require a pap smear.
Known contraindication or hypersensitivity to ingredients or excipients of the IMP, including:
Presence or risk of a venous thromboembolism (VTE)
Venous thromboembolism - existing VTE (even under treatment with anticoagulants) or history of VTE* (e.g., deep venous thrombosis [DVT] or pulmonary embolism [PE])
including a positive family history (VTE ever in a sibling or parent in particular at an age before 50 years)
Known hereditary or acquired predisposition for VTE, e.g., activated protein C (APC) resistance (including Factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency, or prothrombin-related thrombophilia
Major surgery with prolonged periods of immobilization
High risk of venous thromboembolism due to the presence of multiple risk factors
Presence or risk of an arterial thromboembolism (ATE)
Arterial thromboembolism - existing ATE, history of ATE (e.g., myocardial infarction) or prodromal condition (e.g., angina pectoris)
Cerebrovascular disease - existing stroke, stroke or prodromal disorder (e.g., history of transient ischemic attack [TIA])
Known hereditary or acquired predisposition for ATE, e.g., hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulants)
History of migraine with focal neurological symptoms
High risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as diabetes mellitus with vascular damage, severe hypertension, severe dyslipoproteinemia, smokers or existing or previous pancreatitis, if it is associated with severe hypertriglyceridemia
Existing or previous liver diseases in which liver function has not returned to normal (also Dubin-Johnson and Rotor syndrome)
Existing or previous liver tumors
Known or suspected sex hormone-dependent malignant tumors (e.g., breast or endometrium)
Unexplained vaginal bleeding
Hypersensitivity to the active ingredients or any of the excipients

Where it is running

Fellows Research Alliance, Inc. — Savannah, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.