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

NCT03945513 | Completed Phase 3 FDA Drug

• 1 other identifier: LPRI424/303
• Study Type: interventional
• Target: 1,034
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contraception

Keywords

contraception; hormonal oral contraceptive agents; hormonal oral contraceptive; oral contraceptive

Outcome Measures

Primary Outcomes (1)

• Number of pregnancies (evaluable cycles)

  Pearl index (PI) from evaluable cycles in non-breastfeeding women aged ≤ 35 years (at the time of trial enrollment)

  up to 13 months

Secondary Outcomes (7)

• Number of pregnancies (all)

  up to 13 months

• Number of pregnancies (method failures)

  up to 13 months

• Pregnancy ratio

  up to 13 months

• Overall PI, PI for method failures in all women

  Up to 13 months

• Overall PI, PI for method failures in women >35 years

  Up to 13 months

Study Arms (1)

LPRI424

EXPERIMENTAL

Dienogest 2 mg / ethinyl estradiol 0.02 mg tablet orally once daily for 24 days followed by 4 placebo tablets for a 28 day cycle, for 13 cycles

Drug: LPRI424 (dienogest/ethinylestradiol)

Interventions

LPRI424 (dienogest/ethinylestradiol) DRUG

One LPRI424 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.

LPRI424

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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):

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)

Sponsors & Collaborators

• Insud Pharma: lead
• Chemo Research: collaborator

Study Sites (1)

Fellows Research Alliance, Inc.

Savannah, Georgia, 31406, United States

Location

MeSH Terms

Interventions

dienogest; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Enrico Colli, MD

  Chemo Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: December 3, 2019
• Primary Completion: June 30, 2023
• Study Completion: September 8, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

US (1)