Contraception
Conditions
Interventions
Trade Name: Jaydess
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: LEVONORGESTREL
CAS Number: 17489-40-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Institut de Recerca HSCSP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy female subject. - Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method. - History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 106 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria. - Contraindications to use 13,5 LNG-IUD. - Anemia. - Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion. - Known bleeding irregularities. - Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the menstrual bleeding profile among cooper and 13,5 LNG-IUD users. Hypothesis: 13,5 LNG-IUD users have less quantity and fewer days of menstrual bleeding that cooper IUD users. Among 13,5 LNG-IUD users the total blood loss per cycle progressively decreases with continued use. The number of spotting and menstrual bleeding days may initially increase but then decrease in the months that follow.;Secondary Objective: To evaluate: - Spotting pattern. - Satisfaction and quality of life. - Continuation rates after 1st, 2nd and 3rd year. - Pain profile and adverse events.;Primary end point(s): - Number of menstrual bleeding days. Time frame: daily recorded during 90 days treatment period. - Menstrual bleeding characterization (intensity, pattern). Time frame: for 90 days treatment period. Classified using a 5-item Likert-like scale from ?none? to ?heavy? and a pictorial blood loss assessment chart (PBAC). - Serum hemoglobin, hematocrit and ferritin levels.;Timepoint(s) of evaluation of this end point: Daily recorded during 90 days treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of spotting days. Time frame: daily recorded during 90 days treatment period. - Spotting bleeding characterization (intensity, pattern). Time frame: for 90 days treatment period. Classified using a 5-step scale from ?none? to ?heavy? and a pictorial blood loss assessment chart (PBAC). - Global satisfaction with 13,5 LNG-IUD using a 5-item Likert-like scale(from extremely unsatisfied to extremely satisfied). Time frame: at the single visit. - Quality of life after 1st, 2nd and 3rd year. Time framer: at the single visit - Continuation rate after 1st, 2nd and 3rd year. Time frame: at the single visit. - Adverse events as a measure of safety and tolerability.;Timepoint(s) of evaluation of this end point: Daily recorded during 90 days treatment period. | — |
Countries
Spain
Contacts
Public ContactServicio Ginecología y Obstetricia
Institut de Recerca HSCSP
Outcome results
None listed