Evaluation of a progesterone vaginal ring as a new contraceptive option in India
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 20
- 主要终点
- 1.To confirm the contraceptive safety [inclusive of reports of adverse events (AEs) and serious adverse events (SAEs), results of medical examinations and laboratory safety studies] and efficacy (failure rate) of the progesterone vaginal ring (PVR) as compared to the Copper T 380A IUD in breastfeeding women during the first postpartum year.
研究概览
简要总结
This study is an open-label, multicentre trial to confirm the contraceptive efficacy, safety and acceptability of PVR releasing micronized progesterone (10 mg/day) and to compare the PVR with the Copper T380A intrauterine device (IUD) in breastfeeding women initiating use at 6 weeks postpartum. Approximately 1500 to 1600 exclusively breast feeding women who have selected the PVR or IUD as their contraceptive method, aged 20 to 35 years with normal healthy infants, wishing to continue breastfeeding for at least one year and meet all other eligibility criteria will participate at 20 ICMR study centers; approximately half the participants will use the PVR and half will use the IUD. Method use will begin at 6-9 weeks postpartum. Women selecting the PVR will use the method for 12 months or until weaning (fewer than 4 breast feeds per day); they will obtain a new PVR from the study center every 90 ± 5 days. At study end or weaning, they will be offered another contraceptive method of their choice, if desired. Women using the IUD may continue to use this method after weaning. Women will return to the study center for evaluations at 1 week, 1, 3, 6, 9, and 12 months or at weaning. After treatment, women using a contraceptive method or abstaining will be followed for 1 month; those wishing to become pregnant will be followed until pregnancy or up to 12 months, whichever comes first. The purpose of this project is to complete the development of a progesterone vaginal ring (PVR) that was shown to be effective in previous clinical studies to prolong lactational amenorrhea (LAM) and for the spacing of pregnancies. This technology could be of interest in many other countries including xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India as another contraceptive choice for spacing births. However there is a need to conduct studies in Indian women to evaluate the efficacy, safety and acceptability of this new method in this region. Other assessments will include demographic information, including age, body weight, height, education, socio-economic status, obstetric history of the mother and weight/length of the infant. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Able to provide informed consent 2.Age 20 to 35 years (inclusive) 3.Delivered a healthy singleton infant 6 to 9 weeks prior to study enrollment 4.Has at least one (1) living child and is exclusively breastfeeding the new infant (no supplementary feedings) 5.The new breast fed infant’s weight is more than -2SD as per WHO weight for age standards 6.Experienced a normal post partum period 7.Is in good health as confirmed by medical history, physical examination (including vital signs), pelvic/breast examination, and results of laboratory tests at the screening visit 8.Willing to continue breastfeeding at least for one year 9.Has or expects to have regular exposure to the risk of pregnancy 10.Not currently using any method of contraception including barrier or conventional (abstinence, withdrawal, safe period) methods 11.Willing to be counseled on all methods of contraception & choose one study method (PVR/IUD) 12.Willing and able to follow study procedures & come to study center for study visits as described in the protocol 13.Expects to continue living in an area accessible to the study center for the duration of the study.
排除标准
- •1.Are pregnant or are suspected of being pregnant 2.Giving supplementary feeds to the new infant 3.Clinically relevant genital prolapse 4.Had postpartum endometritis or puerperal sepsis 5.Had pelvic inflammatory disease or salpingitis since delivery 6.Are hypersensitive to hormonal preparations or silicone rubber 7.History of generalized urticaria 8.Any chronic condition requiring continuous or regular use of medication 9.Known or suspected diabetes or thyroid disease 10.History of thrombophlebitis or thromboembolism 11.Has a cerebrovascular disorder or coronary artery disease 12.History of and/or current incapacitating migraine 13.Confirmed hypertension or a history of severe pre-eclampsia 14.Neurovascular lesion of the eye or serious visual disturbance at screening 15.History of and/or current depression 16.History of epilepsy or convulsive disorder 17.Known or suspected hepatic adenomas or carcinomas 18.Had an ectopic pregnancy 19.Untreated acute cervicitis or vaginitis 20.Has vaginal bleeding not attributable to menses 21.Current Pap smear suggestive of high-grade pre-cancerous lesion(s), including HGSIL, CIN I and moderate or severe dysplasia 22.Known or suspected uterine or cervical malignancy
- •Known or suspected carcinoma of the breast 24.Has any other known or suspected neoplasia 25.Not cohabiting (not exposed to risk of pregnancy) 26.History of hepatitis or pregnancy-related jaundice 27.History of chronic constipation (for women who choose PVR only) 28.Use of chronic medications, Rifampicin, Griseofluvin, barbiturates, phenytoin, ketoconozole, butazoliden 29.Hemoglobin less than 8 g/dl (colorimeter method for cynmeth Hemoglobin ) 30.Urine for albumin, sugar and microscopic examination indicates abnormal results 31.Blood Pressure- systolic more than 130 mm Hg and/or diastolic more than 85 mm Hg.
结局指标
主要结局
1.To confirm the contraceptive safety [inclusive of reports of adverse events (AEs) and serious adverse events (SAEs), results of medical examinations and laboratory safety studies] and efficacy (failure rate) of the progesterone vaginal ring (PVR) as compared to the Copper T 380A IUD in breastfeeding women during the first postpartum year.
时间窗: First postpartum year.
2. To confirm and compare the continuation rate of PVR and the IUD in breastfeeding women during the first postpartum year.
时间窗: First postpartum year.
次要结局
- 1. infant growth (weight, length, WHO growth curve)(2. vaginal bleeding patterns (bleeding/spotting episodes))
- 7. health care providers’ knowledge and attitudes about the methods and their use(8. factors influencing acceptability and perception of PVR and Copper T 380A)