Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia

Mansoura University

Status: Completed

Conditions: Menorrhagia

Treatments: Drug: NuvaRing; Drug: Norethisterone Acetate tablets - 5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01266759

MU-261z

FMH-245-C

Details and patient eligibility

About

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

Enrollment: 95 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 2 patient groups

NuvaRing

Experimental group

Description:

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.

Treatment:

Drug: NuvaRing

Norethisterone Acetate

Active Comparator group

Description:

Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment

Treatment:

Drug: Norethisterone Acetate tablets - 5mg