CTRI/2024/08/072277 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On:
05/01/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Study to evaluate the bioequivalence and safety of Etonogestrel Implant in Healthy Female Participants
Scientific Title of Study
A Multi-Center, Open-Label, Randomized, Single Dose, Parallel Design, In Vivo/Ex Vivo Pharmacokinetic study of LSP-9759 (etonogestrel implant, 68 mg) and Nexplanon®, etonogestrel implant, 68 mg in Healthy Female Participants
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: LSP-9759-101 Version: 1.0 Date: 26 Feb 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research limited
Address
Cliantha Research, Department Clinical Trials, Room no. 01, 2nd floor, #06, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad - 380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
07966219555
Fax
07966219549
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director-II Medical Services
Affiliation
Cliantha Research limited
Address
Cliantha Research, Department Clinical Trials, Room no. 01, 2nd floor, #06, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad - 380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
07966219555
Fax
07966219549
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Hitesh Maheshwari
Designation
Associate Director-II Clinical Trials
Affiliation
Cliantha Research limited
Address
Cliantha Research, Department Clinical Trials, Room no. 01, 2nd floor, #06, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad - 380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
07966219577
Fax
07966219549
Email
hmaheshwari@cliantha.com
Source of Monetary or Material Support
Loop Therapeutics LLC, 9450 Bryn Mawr, Suite 200, Rosemont, IL 60018, USA
Primary Sponsor
Name
Loop Therapeutics LLC
Address
9450 Bryn Mawr, Suite 200, Rosemont, IL 60018, USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Cliantha Research Limited
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
A single rod-shaped implant inserted on Day 1 and removed on Day 183 (or ET).
Comparator Agent
Nexplanon®, etonogestrel implant, 68 mg
A single rod-shaped implant inserted on Day 1 and removed on Day 183 (or ET).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Female
Details
1. Must be able, and willing, to give written Informed Consent prior to study participation in accordance with legal requirements and in a language that the participant understands.
2. Healthy, premenopausal, nonpregnant females, ages 18 to 45 years (inclusive), who are not using other hormonal contraceptive methods.
3. Have a regular menstrual cycle (21 - 35 day cycles) without hormonal contraceptive use and at time of planned implantation (Study Day 1) be on Days 1-5 of menstrual cycle.
4. Body Mass Index (BMI) of 18.5 kg/m2 to 30.0 kg/m2, and weight ≥45 kg.
5. Participants must be in good physical and mental health as determined by vital signs, clinical laboratory testing, physical examination, breast examination, and medical history.
6. Participants must have a negative chlamydia and gonorrhea test at Screening.
7. If heterosexually active, WOCBP must agree to use contraception considered medically adequate and appropriate throughout the course of the study and for 1 month after the removal of the implant. Acceptable contraception methods are:
a. Vasectomized partner (at least 6 months before enrollment)
b. Double barrier method (e.g., diaphragm with spermicide; condoms with spermicide)
c. Abstinence (must agree to use a double barrier method if they become sexually active during the study)
ExclusionCriteria
Details
1. Postmenopausal females.
2. Weight greater than 130% of ideal body weight.
3. Pregnancy, a positive pregnancy test at Screening or Study Day -1 or lactation, or plans to become pregnant during the study.
4. Vaginal delivery, cesarean delivery, or abortion within six weeks prior to implantation.
5. Known or suspected uterine or cervical neoplasia, now or in the past.
6. Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past.
7. Undiagnosed vaginal discharge or undiagnosed/abnormal uterine bleeding.
8. Participants with abnormal pap smears that require colposcopic evaluations as defined by the Fourth American Society of Colposcopy and Cervical Pathology (ASCCP) sponsored guidelines for management of cervical cancer abnormalities during the next 6 months are excluded. Participants with abnormal pap smear and who have undergone colposcopic evaluation which has determined that a cervical procedure is not necessary during the 6 months following the colposcopy are allowed.
9. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections.
10. Past or present history of acute liver disease or liver tumor (benign or malignant).
11. A previously inserted intrauterine device (hormonal or non-hormonal) that has not been removed within 8 weeks prior to Study Day 1.
12. Use of long-acting injectable contraceptive (depo-medroxyprogesterone) with a dose given within six months prior to Study Day 1 and at least 2 menstrual periods prior to Study Day 1.
13. Prior implanted contraception with removal less than 3 months prior to Study Day 1.
14. Prior use of oral contraceptives within 1 month to Study Day 1.
15. History or evidence of any clinically significant (as determined by the investigator) cardiovascular (including hypertension), gastrointestinal, endocrine, gynecologic, ophthalmologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including asthma or emphysema), neurologic, dermatologic, psychiatric (including depression), renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer).
16. Clinically significant findings from clinical laboratory tests at screening.
17. Participant has a positive test for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) or syphilis (VDRL) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
18. Clinically significant electrocardiogram (ECG) findings or QTcF greater than 450 msec at Screening.
19. Participant has a known hypersensitivity reaction or contraindication to progesterone or any components of the formulation.
20. History of thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction).
21. History of surgery to the veins or arteries of the lower extremities or findings on physical exam such as presence of significant varicosities and peripheral edema.
22. Past, present, family history, known hereditary or acquired predisposition for venous and/or arterial thromboembolism (e.g., activated protein C (APC) resistance, anti-cardiolipin antibodies, or coagulopathy).
23. Participants at increased risk for infectious endocarditis (e.g., prosthetic heart valves, rheumatic heart disease, previous endocarditis).
24. History of migraine with focal neurological symptoms.
25. Less than 4 weeks remobilization after major surgery or prolonged immobilization.
26. Alcohol, drug, or medicine (prescription or recreational) abuse, or suspicion thereof or the participant tests positive at screening or Study Day -1 for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
27. Participant is a current smoker, nicotine, or tobacco user in any form or has used nicotine or tobacco containing products within the past 6 months.
28. Participant has used prescription or non-prescription drugs including herbal and iron supplements within 2 weeks or 5 half-lives (whichever is longer) prior to enrollment (excluding paracetamol/acetaminophen (≤ 3 grams per day), ibuprofen (≤ 1200 mg/day), naproxen sodium (≤ 660 mg/day) and levocetirizine (≤ 5mg/day)).
29. Participation in another clinical trial at the same time or within the preceding three months or has received an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
30. Participant has a sitting mean systolic blood pressure less than 90 or greater than 140 mmHg and a mean diastolic blood pressure less than 50 or greater than 90 mmHg, or pulse rate higher than 100 beats per min (bpm), either at screening or clinic check in (measurements taken in duplicate after participant has been resting in a sitting position for a minimum of 5 minutes).
31. Participant had a significant blood loss or donated one unit (450 mL) of blood within 60 days or donated plasma or platelets (one unit) within 30 days prior to Study Day 1.
32. Participant has an estimated glomerular filtration rate (eGFR) less than 80 mL/min/1.73 m2.
33. Participant has a history of difficulty with vascular access for study blood draws.
34. Participant has a history of allergic conditions or anaphylactic reactions including drug allergies (excluding untreated seasonal allergies or seasonal allergies treated by antihistamines).
35. Participant has/had a febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in.
36. Participant has any other condition, which in the opinion of the Investigator, precludes the participant’s participation in the study or the participant is unlikely to comply with the protocol-defined procedures or complete the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
The primary objective of this parallel study is to demonstrate bioequivalence between LSP-9759 (etonogestrel implant, 68 mg, Loop Therapeutics, LLC) and Nexplanon®, etonogestrel implant, 68 mg (Organon Global Inc.) at 26 weeks after implantation.
Day 1 to Day 183 (or ET)
Secondary Outcome
Outcome
TimePoints
The safety objective is to assess the safety & tolerability of LSP-9759 & Nexplanon® in healthy adult female participants.
26 weeks
Target Sample Size
Total Sample Size="310" Sample Size from India="310" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is an open-label, randomized parallel design, in
vivo/ex vivo, bioequivalence study in healthy, premenopausal adult female
participants.
Up to 310 adult female healthy participants will be
randomized (1:1) to receive either LSP-9759 or Nexplanon® to achieve 222
completed participants. After 26 weeks of treatment the implant will be removed
and residual amount of etonogestrel will be assessed.
Participants who meet all study inclusion and no study
exclusion criteria will be randomized to receive either LSP-9759 or Nexplanon
on Study Day 1. The randomization will be stratified by site and participant
BMI (<20.0, 20.0-24.9, ≥25.0 kg/m2) based on participant’s Day -1 weight.
At time of implantation, the participant must be between
Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even
if the participant is still bleeding.
Participants will be admitted to the clinic on Study Day
-1 and will remain in the clinical for at least 72 hours after implantation of
the study drug to allow for safety monitoring and PK sample collection.
Participants will also return for a total of 12 outpatient
visits for safety monitoring and PK sample collection and on Study Day 183 for
safety monitoring, PK sample collection and removal of the study drug implant.
A total of 21 pharmacokinetic samples (7.0 mL each) will
be collected from each participant.
Pharmacokinetic samples will be
taken at Pre-Dose (up to 2 hours prior to implantation) and at 2, 4, 6, 8, 12,
24 (Study Day 2), 48 (Study Day 3), 72 (Study Day 4), 96 (Study Day 5), 120
(Study Day 6), 168 (Study Day 8), 240 (Study Day 11), 336 (Study Day 15), 504
(Study Day 22), 672 (Study Day 29), 1344 (Study Day 57), 2016 (Study Day 85),
2688 (Study Day 113), 3360 (Study Day 141) and 4368 (Study Day 183) hours post
dose.