Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality

Istanbul Training and Research Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Contraceptive Methods Comparison

Treatments: Device: levonorgestrel-releasing system; Device: The Copper-T is an intrauterine device (IUD); Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)

Study type: Interventional

Funder types: Other

Identifiers

NCT01805817

cuzuncakmak1907

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria were pelvic inflammatory disease, pregnancy, genital tumor or thromboembolic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Levonorgestrel releasing intrauterine device, contraception

Experimental group

Description:

LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year

Treatment:

Device: The Copper-T is an intrauterine device (IUD)

Device: levonorgestrel-releasing system

Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)

YASMIN® (Drospirenone/Ethinyl Estradiol), contraception

Experimental group

Description:

oral, once a day, 1 year

Treatment:

Device: The Copper-T is an intrauterine device (IUD)

Device: levonorgestrel-releasing system

Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)

Copper T 380 A , contraception

Experimental group

Description:

intrauterine device, once per 10 year, 1 year period

Treatment:

Device: The Copper-T is an intrauterine device (IUD)

Device: levonorgestrel-releasing system

Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)