Comparative Study of Efficacy and Safety Lynestrenol versus Exluton® in Women of Childbearing Age
Tahapan Penelitian : Complete
Sponsor:
PT. Triyasa nagamas Farma
Mitra Pelaksana:
PT. Equilab International
No Registry
INA-N910C51
Tanggal Input Registry : 19-10-2018
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 15-10-2017 |
| Outcome Primer | The occurrence of pregnancy (Pearl Index), assessed with the urine HCG test in each visit |
| Outcome Skunder | Safety/tolerability, assessed based on adverse events occurred |
| Descriptive Information | |
| Judul Penelitian Popular | Comparative Study of Efficacy and Safety Lynestrenol versus Exluton® in Women of Childbearing Age |
| Judul Penelitian Ilmiah | An Opened, Randomized, Comparative Study of Efficacy and Safety of 0.5 mg Lynestrenol Tablet Produced by PT Triyasa Nagamas Farma Versus the Reference Product (Exluton@, PT Sydna Farma lndonesia) in Women of Childbearing Age |
| Jenis Penelitian | Observasional |
| Intervensi | This is a prospective, randomized, open label, comparative, parallel study to evaluate efficacy and safety of 0.5 mg lynestrenol during 12 months of drug administration. The randomization code is tabulated for all subjects according to block randomization with a block size of 4 (Dixon & Massey, 1969, p 447). The study will be conducted in PT Equilab International as the study center in collaboration with some midwife clinics in Jakarta and surrounding areas. The data of pregnancy occurrence will be evaluated by urine HCG test every 2 months at until 12 months of evaluation period. The data of adverse events occurred during the study will be collected based on subject’s diary, anamnesis, and medical examination. Subjects are not allowed to use other contraception except the investigational product (0.5 mg Lynestrenol that dispensed from the study site) |
| Jumlah Subyek Penelitian | 400 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Woman of childbearing age, age : 20-40 years old 2. Woman who intend to use oral hormonal contraceptive 3. Married woman, sexually active, living with her husband, has the potential to become pregnant 4. Minimally has one child 5. Woman who already received explanation, understanding the objective of the study including the possibility of risks and willing to sign the written informed consentExclusion Criteria: 1. Use of any hormonal contraception within 3 months prior to screening for this study 2. Pregnant woman 3. IUD, abstinence, or sterilization contraceptive method including tubectomy 4. History or presence of infertility 5. History or presence of some conditions as follows :undiagnosed vaginal bleeding; cardiovascular disease (including: hypertension, coronary disease, active venous thromboembolic disorders, arterial disease, etc); hepatic impairment; malignancy; renal disease; epilepsy; migraine; asthma; diabetes mellitus; post ectopic pregnancy; known hypersensitivity to lynestrenol or any ingredient in the formulation 6. Any other known current medical condition, which, is judged by the investigator could jeopardize subject’s health or interfere with the study evaluation |
| Administrative Information | |
| Nomor Persetujuan Etik | 188/UN2.F1/ETIK/II/2017 |
| Nomor Persetujuan Material Transfer Agreement | - |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PN.01.06.313.3.03.1 7.1440 |
| Other Study ID Numbers | - |
| Contact Person | siskaoey@triyasa.com ; sortasaulina@triyasa.com ; rndstaff@triyasa.com |