Menorrhagia
Conditions
Keywords
Menorrhagia, Vaginal ring, Norethisterone Acetate
Brief summary
To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age
Interventions
DRUGNuvaRing
For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.
DRUGNorethisterone Acetate tablets - 5mg
Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception
Exclusion criteria
* Menorrhagia of endocrine or systemic origin * other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart. | — |
Secondary
| Measure | Time frame |
|---|---|
| Haemoglobin and serum ferritin at the end of study (cycle 3) | — |
Countries
Egypt
Outcome results
None listed