Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Meir Medical Center
• Treatments: Anesthetics; Tramadol

Criteria

Inclusion Criteria:

• Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent.

Exclusion Criteria:

Women suffering from:

• Acute or recurrent pelvic inflammatory disease.

• Acute cervicitis or acute Vaginitis.

• Current cervical intraepithelial lesion.

• Current any genital malignancy.

• Progesterone hypersensitivity.

• progesterone-sensitive tumours (e.g. breast tumours).

• Abnormal vaginal bleeding.

• Congenital or acquired uterine anomaly.

• Distorted uterine cavity e.g. fibroid or polyp.

• Impaired liver functions, or liver tumour.

• Known hypersensitivity to the active substance or to any of the excipients of Jaydess.

• Contraindications to Tramadol according to approved product information:

• In hypersensitivity to tramadol or any of the excipients.

• In patients who are receiving monoamine oxidase inhibitors or within 2 weeks (14 days) of their withdrawal.

• In patients with epilepsy not adequately controlled by treatment.

• Vaginismus.