LNG-IUS for Treatment of Dysmenorrhea
Atslēgvārdi
Abstrakts
Datumi
Pēdējoreiz pārbaudīts: | 10/31/2017 |
Pirmais iesniegtais: | 05/14/2012 |
Paredzētā reģistrācija iesniegta: | 05/15/2012 |
Pirmais izlikts: | 05/17/2012 |
Pēdējais atjauninājums iesniegts: | 11/19/2017 |
Pēdējā atjaunināšana ievietota: | 11/21/2017 |
Faktiskais studiju sākuma datums: | 03/31/2012 |
Paredzamais primārās pabeigšanas datums: | 03/31/2013 |
Paredzamais pētījuma pabeigšanas datums: | 03/31/2015 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Device: LNG-IUS (Mirena)
Drug: Combined oral contraceptives
Fāze
Roku grupas
Roka | Iejaukšanās / ārstēšana |
---|---|
Experimental: LNG-IUS (Mirena) Group I "the LNG-IUS group" where they will have a LNG IUS (mirena) inserted for them | Device: LNG-IUS (Mirena) The study includes 2 treatment groups: Group I "the LNG-IUS group" where they will have a LNG IUS inserted for them |
Active Comparator: Combined oral contraceptives Group II "COCs group" where they will receive low dose combined oral contraceptive pills for 6 months | Drug: Combined oral contraceptives Group II: will recite combined oral contraceptives for 6 months |
Atbilstības kritēriji
Vecums, kas piemērots studijām | 20 Years Uz 20 Years |
Dzimumi, kas ir piemēroti studijām | Female |
Pieņem veselīgus brīvprātīgos | Jā |
Kritēriji | Inclusion Criteria: 1. Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis. 2. Planning for birth spacing for at least 2 years. 3. Patient aged between 20-45 years old. 4. Ultrasonographic and Doppler examination suggestive of adenomyosis. 5. Living in a nearby area to make follow-up reasonably possible. Exclusion Criteria: 1. Pregnancy 2. Evidence of defective coagulation. 3. History or evidence of malignancy. 4. Hyperplasia in the endometrial biopsy. 5. Incidental adnexal abnormality on ultrasound. 6. Contraindications to COCs. 7. Absolute contraindication of LNG-IUS insertion. 8. Previous endometrial ablation or resection 9. Uninvestigated postcoital bleeding 10. Untreated abnormal cervical cytology |
Rezultāts
Primārie rezultāti
1. Visual analogue score (VAS) for dysmenorrhea or chronic pelvic pain will be measure before after use LNG_IUS and COCs. [6 month]
Sekundārie iznākuma mērījumi
1. Menstrual blood loss: assessment of blood loss, measured at the beginning of intervention and for 3 months [6 month]