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Jadelle

Manufactured by Bayer
Sourced in Finland

Jadelle is a contraceptive implant that contains two small, slender, flexible rods made of a plastic-like material. The rods are implanted under the skin of the upper arm and release a continuous, low dose of the progestogen hormone levonorgestrel to prevent pregnancy.

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Lab products found in correlation

5 protocols using jadelle

1

Contraceptive Methods and Weight Change

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At enrolment, women were randomly assigned (1:1:1) to the DMPA-IM group, Copper IUD group, or LNG implant group. Participants received a Cu IUD (Optima TCu380A; Injeflex, Sao Paolo, Brazil), an LNG implant (Jadelle; Bayer, Turku, Finland) or an injection of 150 mg/mL DMPA-IM (Depo Provera; Pfizer, Puurs, Belgium), which was provided on site at enrolment and for the DMPA-IM group at every 3-monthly follow-up visit up to 18 months.
Ethics review committees at each study site, FHI 360, and the World Health Organization (WHO) approved the study protocol. Women provided written informed consent in a language of their choice prior to the conduct of any study related procedures.
Outcomes: The primary outcome of this secondary analysis is weight change from study enrolment to the final visit at study month 12–18.
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2

Pharmacokinetics of LNG Implants in Ugandan Women on Efavirenz-based ART

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We conducted a non-randomized, open-label, longitudinal pharmacokinetic study to assess the safety and pharmacokinetics of 300mg LNG subdermal implants (2 × 2-rod 75mg LNG/rod; Jadelle®; Bayer, New Zealand) among Ugandan women taking efavirenz-based ART (300LNG+ART group, n=27) [11 ]. We compared outcomes with a contemporaneous cohort of 19 adult Ugandan women without HIV and not on efavirenz-based ART receiving standard dose LNG implant (1 × 2-rod 75mg LNG/rod; 150LNG group) [12 (link)]. Investigators performed study-related procedures at the Infectious Diseases Institute (IDI), Makerere University College of Health Sciences, Kampala, Uganda, in accordance with the Declaration of Helsinki. Ethics boards at the Joint Clinical Research Centre Kampala, Uganda National Council for Science and Technology, and the University of Nebraska Medical Center approved all study procedures. All volunteers provided written informed consent. This study is registered in ClinicalTrials.gov (Identifier: NCT02722421).
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3

Randomized Contraceptive Comparison Study

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At enrolment, women were randomly assigned (1:1:1) to DMPA-IM, copper IUD or LNG implant.6 (link) Participants received an injection of 150 mg/mL DMPA-IM (Depo Provera; Pfizer, Puurs, Belgium) at enrolment and every 3 months until the final visit at 18 months after enrolment, a copper IUD (Optima TCu380A; Injeflex, Sao Paolo, Brazil) or a LNG implant (Jadelle; Bayer, Turku, Finland) at enrolment. Women returned for follow-up visits at 1 month after enrolment to address initial contraceptive side-effects and every 3 months thereafter, for up to 18 months with later enrolling participants contributing 12 to 18 months of follow-up. Visits included HIV serological testing, contraceptive counselling, syndromic STI management and safety monitoring.
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4

Comparison of Contraceptive Effectiveness

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DMPA IM 150 mg/1 ml (Depo Provera, Pfizer) is a 3-monthly progestogen-only injectable with a 0.2% failure rate with perfect use, but a 6% failure rate with typical use
18 . The LNG implant (Jadelle, Bayer) consists of two silicone rods each containing 75 mg of LNG and is highly effective and user independent, with failure rates of <1% for both perfect and typical use
19 (link). The T-380A copper IUD, when inserted correctly, has failure rates of <1% in the first year, and only 2.2% in the first 10 years of use
20 (link). The contraceptive methods were purchased or donated by USAID or the South African government. The manufacturers were not involved in the design or execution of the trial.
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5

ECHO Contraceptive Effectiveness Trial

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Following online registration, the ECHO trial centrally randomized participating women to DMPA‐IM (150 mg/ml, Depot‐Provera®; Pfizer, Puurs, Belgium) given intramuscularly every 12 weeks, insertion of the Copper IUD (Optima TCu380A®; Injeflex, Sao Paolo, Brazil) at enrollment, or insertion of the subdermal LNG implant (150 mg, Jadelle®; Bayer, Turku, Finland) at enrollment. Participant and personnel blinding was not possible because of the nature of the interventions, and participant follow up was conducted at 1, 3, 6, 9, 12, 15, and 18 months. ECHO participants at our site who additionally consented to participate in this ancillary study were enrolled at the 1‐month ECHO follow‐up visit, and were interviewed at the 3‐ and 12‐month visits for this purpose by trained research assistants. The 12‐month follow up was an extension of the protocol that had originally planned a 3‐month follow up only. Some participants (n = 53) only contributed data at the 12‐month visit.
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