A study to compare the menstrual bleeding profile among Jaydess® and Cooper IUD users

• Conditions: Contraception; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2015-004956-23-ES
• Lead Sponsor: Institut de Recerca HSCSP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Healthy female subject.
- Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method.
- History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria.
- Contraindications to use 13,5 LNG-IUD.
- Anemia.
- Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion.
- Known bleeding irregularities.
- Pregnancy or breast-feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified