FR01 and FR20 IUS (Intrauterine System) Wearing Study

Bayer

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: Placebo: Flexi ring FR20; Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS); Drug: Placebo: Flexi ring FR01

Study type: Interventional

Funder types: Industry

Identifiers

NCT01595022

13830

Details and patient eligibility

About

The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Female subject
• Age 18-40 years (inclusive)
• History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
• Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
• Confirmed uterine sound depth of 6 to 10 cm

Exclusion criteria

• Pregnancy or lactation
• Sterilized
• Nulliparous
• Congenital or acquired uterine anomaly
• Vaginal or cesarean delivery within 8 weeks prior to insertion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

Flexi ring FR01

Placebo Comparator group

Treatment:

Drug: Placebo: Flexi ring FR01

Flexi ring FR20

Placebo Comparator group

Treatment:

Drug: Placebo: Flexi ring FR20

Ultra low dose LCS

Placebo Comparator group

Treatment:

Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)