Trial Outcomes & Findings for Contraceptive Effectiveness and Safety of the SILCS Diaphragm (NCT NCT00578877)

NCT ID: NCT00578877

Last Updated: 2018-03-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 450 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-03-16

Participant Flow

Participant milestones

Measure	N-9 Gel With SILCS Diaphragm Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles	BufferGel With SILCS Diaphragm Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
Overall Study STARTED	150	300
Overall Study COMPLETED	69	172
Overall Study NOT COMPLETED	81	128

Reasons for withdrawal

Measure	N-9 Gel With SILCS Diaphragm Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles	BufferGel With SILCS Diaphragm Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
Overall Study Lost to Follow-up	8	10
Overall Study early discontinue	61	101
Overall Study did not provide follow-up data	12	17

Baseline Characteristics

Contraceptive Effectiveness and Safety of the SILCS Diaphragm

Baseline characteristics by cohort

Measure	N-9 Gel With SILCS Diaphragm n=138 Participants Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles	BufferGel With SILCS Diaphragm n=283 Participants Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles	Total n=421 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	138 Participants n=5 Participants	283 Participants n=7 Participants	421 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.2 years STANDARD_DEVIATION 6 • n=5 Participants	28.7 years STANDARD_DEVIATION 6.0 • n=7 Participants	28.9 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	283 Participants n=7 Participants	421 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	138 participants n=5 Participants	283 participants n=7 Participants	421 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	N-9 Gel With SILCS Diaphragm n=138 Participants Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles	BufferGel With SILCS Diaphragm n=283 Participants Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
Percent Probability of Pregnancy Among Users of the SILCS Diaphragm Used With Contraceptive Gel Over 6 Months of Typical Use	12.5 percent probability	9.6 percent probability

SECONDARY outcome

Timeframe: 6 months

Clinically evaluate the safety of the SILCS diaphragm used with contraceptive gel over 6 months of use.

Outcome measures

Outcome data not reported

Adverse Events

N-9 Gel With SILCS Diaphragm

Serious events: 1 serious events

Other events: 85 other events

Deaths: 0 deaths

BufferGel With SILCS Diaphragm

Serious events: 3 serious events

Other events: 179 other events

Deaths: 0 deaths

Serious adverse events

Measure	N-9 Gel With SILCS Diaphragm n=137 participants at risk Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles	BufferGel With SILCS Diaphragm n=278 participants at risk Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
Injury, poisoning and procedural complications Intentional Suicide	0.00% 0/137 • 6 months	0.36% 1/278 • Number of events 1 • 6 months
Cardiac disorders Myocardial Infarction	0.73% 1/137 • Number of events 1 • 6 months	0.00% 0/278 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/137 • 6 months	0.36% 1/278 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Post Surgical Infection	0.00% 0/137 • 6 months	0.36% 1/278 • Number of events 1 • 6 months

Other adverse events

Measure	N-9 Gel With SILCS Diaphragm n=137 participants at risk Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles	BufferGel With SILCS Diaphragm n=278 participants at risk Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
Reproductive system and breast disorders Abnormal vaginal bleeding	15.3% 21/137 • Number of events 21 • 6 months	13.7% 38/278 • Number of events 38 • 6 months
Reproductive system and breast disorders Pain, irritation, pruritus	35.0% 48/137 • Number of events 48 • 6 months	37.4% 104/278 • Number of events 104 • 6 months
Reproductive system and breast disorders Symptomatic vaginal infection	11.7% 16/137 • Number of events 16 • 6 months	13.3% 37/278 • Number of events 37 • 6 months

Additional Information

Jill Schwartz, M.D.

CONRAD

Phone: 703-276-3913

Email: jschwartz@conrad.org

Results disclosure agreements

• Principal investigator is a sponsor employee Data obtained from a clinical trial in which 2 or more research centers participate cannot be published or presented by any of the individual investigators before the end of the clinical trial. Only after publication of the pooled results can data from individual centers be published. When the Principal Investigator wishes to write a paper using data collected from his or her own center, the Recipient Institution agrees to allow CONRAD and USAID the opportunity to review \& provide comments.
• Publication restrictions are in place

Restriction type: OTHER