Trial Outcomes & Findings for A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device (NCT NCT01590563)

Results Overview

Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

During installation

Results posted on

2020-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	SCu300A IUB Insertion of a spherical IUD (intrauterine device) with one year follow-up
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SCu300A IUB Insertion of a spherical IUD (intrauterine device) with one year follow-up
Overall Study simple uterine hyperplasia - not related	1

Baseline Characteristics

A Study to Evaluate the Safety and Initial Efficacy of a Novel Intrauterine Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCu300A IUB n=15 Participants Insertion of a spherical IUD (intrauterine device) with one year follow-up
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	33.9 years STANDARD_DEVIATION 4.8 • n=99 Participants
Sex/Gender, Customized	15 participants n=99 Participants
Region of Enrollment Hungary	15 participants n=99 Participants
Prior Contraception Use Yes	8 participants n=99 Participants
Prior Contraception Use No	7 participants n=99 Participants

PRIMARY outcome

Timeframe: During installation

Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.

Outcome measures

Outcome measures
Measure	Investigated Device Group n=15 Participants Group inserted the investigated device - the IUB SCu300A
Rates of Uterine Perforation	0 Number of cases

PRIMARY outcome

Timeframe: 12 months

Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.

Outcome measures

Outcome measures
Measure	Investigated Device Group n=15 Participants Group inserted the investigated device - the IUB SCu300A
Efficacy in Preventing Pregnancy	0 Number of pregnancies

SECONDARY outcome

Timeframe: 12 months

Expulsion and malposition are established risks involved with IUD use. Occurrence of these risks may drastically reduce effectiveness. It is expected that the IUB(tm) form will reduce these risks.

Outcome measures

Outcome measures
Measure	Investigated Device Group n=15 Participants Group inserted the investigated device - the IUB SCu300A
Occurrence of Malposition, Expulsion.	0 Number of cases

Adverse Events

SCu300A IUB

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SCu300A IUB n=15 participants at risk Insertion of a spherical IUD (intrauterine device) with one year follow-up
Reproductive system and breast disorders Endometrial hyperplasia	6.7% 1/15 • Number of events 1

Additional Information

Dr. Beata Szoczei, MD

Synexus Hungary

Phone: +36 1 436 7330

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place