Contraceptive Methods Comparison
Conditions
Keywords
lipid profile, bleeding scores, menstrual pattern, beneficial, side effects, changes in a year period
Brief summary
Oral combined contraceptives(OC) have both progesterone and estrogen inside. Levonorgestrel-releasing intrauterine device(LNG\_IUS) has only progestagen. Copper IUD does not have any hormonal molecule inside. * Hypothesis is OC has more systemic beneficial or side effects than LNG\_IUS or copper IUD. LNG\_IUS has more local effects than copper IUD. * Study reflects the beneficial or side effects of estrogen+progestagen pills and only progestogen inside device.
Interventions
DRUGYASMIN® (Drospirenone/Ethinyl Estradiol)
oral contraceptive pills
DEVICEThe Copper-T is an intrauterine device (IUD)
intrauterine device for contraception
DEVICElevonorgestrel-releasing system
intrauterine device
Sponsors
Istanbul Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* women who desire contraception
Exclusion criteria
* Women with large fibroids,abnormal uterine bleeding including heavy menstrual bleeding or using any contraceptive pills during the previous 3 months were excluded from the study. Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL)Lng-ius users, Copper-iud users and combined oral contraceptive users (composite measurement) | Change from Baseline HDL,Very-low-density lipoprotein (VLDL),IDL,Low-density lipoprotein (LDL),Lp(a),VLDL concentrations at 3 months; Baseline to 6 months, Baseline to 12 months of outcome will have assessed | 60 lng-ius users, 60 Copper iud users and 60 combined oral contraceptive users will compared with total lipoprotein, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very-low-density lipoprotein (VLDL), lipoprotein(a) (Lp(a)), intermediate-density lipoprotein (IDL ), HDL subclasses , LDL subclasses , VLDL subclasses ,values at 3-6-12 months follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| coagulation parameters(composite measurement) | Change from Baseline aPTT, prothrombin time, INR, D-dimer,factor VIII, fibrinogen, platelet counts values at 3 months; Baseline to 6 months, Baseline to 12 months of outcome will have assessed | 60 lng-ius users, 60 Copper iud users and 60 combined oral contraceptive users will compared with activated partial thromboplastin time (aPTT), prothrombin time, international normalized ratio(INR), D-dimer,factor VIII, fibrinogen, platelet counts values with each other at 3-6-12 months follow up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| menstrual pattern and bleeding scores(composite measurement) | Change from Baseline pictorial blood scoring system scores at 3 months, Baseline to 6 months, Baseline to 12 months will be assessed | 60 lng-ius users, 60 Copper iud users and 60 combined oral contraceptive users menstrual pattern will be recorded and menstrual bleeding scores will be measured by pictorial blood scoring system and it will be compared with each other at 3-6-12 months follow up. |
Countries
Turkey (Türkiye)
Outcome results
None listed