Trial Outcomes & Findings for Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol® (NCT NCT00274261)

Last Updated: 2018-05-01

Results Overview

Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1565 participants

Primary outcome timeframe

6 months

Results posted on

2018-05-01

Participant Flow

Female subjects were screened and enrolled at 15 sites in the US.

Participant milestones

Participant milestones
Measure	C31G C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel	Conceptrol Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
Overall Study STARTED	932	633
Overall Study COMPLETED	443	296
Overall Study NOT COMPLETED	489	337

Reasons for withdrawal

Reasons for withdrawal
Measure	C31G C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel	Conceptrol Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
Overall Study Adverse Event	19	11
Overall Study Pregnancy	114	83
Overall Study Withdrawal by Subject	179	126
Overall Study Protocol Violation	71	42
Overall Study Lost to Follow-up	106	75

Baseline Characteristics

Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C31G n=932 Participants C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel	Conceptrol n=633 Participants Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.	Total n=1565 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	932 Participants n=5 Participants	633 Participants n=7 Participants	1565 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	28.1 years STANDARD_DEVIATION 5.58 • n=5 Participants	28.3 years STANDARD_DEVIATION 5.90 • n=7 Participants	28.2 years STANDARD_DEVIATION 5.71 • n=5 Participants
Sex: Female, Male Female	932 Participants n=5 Participants	633 Participants n=7 Participants	1565 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	932 participants n=5 Participants	633 participants n=7 Participants	1565 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Modified Intent-To-Treat (MITT): ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as "Typical-Use") and for whom there is at least one report of pregnancy status.

Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.

Outcome measures

Outcome measures
Measure	C31G n=827 Participants C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel	Conceptrol n=555 Participants Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.	0.12 6 month probability of pregnancy Interval 0.093 to 0.147	0.12 6 month probability of pregnancy Interval 0.087 to 0.153

SECONDARY outcome

Timeframe: duration of the study - through 6 month or 12 months of use

Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.

Outcome measures

Outcome measures
Measure	C31G n=932 Participants C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel	Conceptrol n=633 Participants Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
Incidence of Adverse Events.	617 Participants	434 Participants

Adverse Events

C31G

Serious events: 10 serious events

Other events: 617 other events

Deaths: 0 deaths

Conceptrol

Serious events: 12 serious events

Other events: 434 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jason Woo, MD, MPH

NICHD

Phone: 301-496-1662

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	C31G n=836 participants at risk C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel	Conceptrol n=560 participants at risk Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
Blood and lymphatic system disorders Anaemia	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Cardiac disorders Palpitations	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Endocrine disorders Diabetic ketoacidosis	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Crohn's Disease	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Food poisoning	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Gastroenteritis escherichia coli	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Gastroenteritis viral	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Nausea	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Hepatobiliary disorders Bile duct stone	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Hepatobiliary disorders Cholelithiasis	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Immune system disorders Hypersensitivity	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Infections and infestations Infection	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Injury, poisoning and procedural complications Laceration	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Musculoskeletal and connective tissue disorders Joint dislocation	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dermoid Cyst	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cyst Ruptured	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Nervous system disorders Meningitis viral	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Psychiatric disorders Acute stress disorder	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Psychiatric disorders Depression	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Renal and urinary disorders Kidney Infection	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Renal and urinary disorders Stress incontinence	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Menorrhagia	0.12% 1/836 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.00% 0/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Pelvic inflammatory disease	0.00% 0/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	0.18% 1/560 • Number of events 1 The overall safety population includes only subjects that actually used the product at least once totalling 1396.

Measure	C31G n=836 participants at risk C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel	Conceptrol n=560 participants at risk Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
Infections and infestations Nasopharygitis	15.6% 130/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	16.4% 92/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Infections and infestations Vaginitis bacterial	12.0% 100/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	13.0% 73/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Infections and infestations Vaginal mycosis	10.4% 87/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	12.5% 70/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Nervous system disorders Headache	9.4% 79/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	11.2% 63/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Infections and infestations Urinary tract infection	9.4% 79/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	10.5% 59/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Metrorrhagia	8.3% 69/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	9.8% 55/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Menstrual cycle prolonged	6.8% 57/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	7.3% 41/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Menstruation irregular	6.7% 56/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	7.3% 41/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Infections and infestations Influenza	6.8% 57/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	6.2% 35/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Dysmenorrhoea	5.9% 49/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	6.6% 37/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Genital pruritus female	3.6% 30/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	5.7% 32/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Musculoskeletal and connective tissue disorders Back pain	4.2% 35/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	4.5% 25/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Oligomenorrhoea	4.5% 38/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	3.4% 19/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Investigations Smear cervix abnormal	3.8% 32/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	4.3% 24/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Pharyngolaryngeal pain	3.8% 32/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	3.6% 20/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Toothache	3.6% 30/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.1% 12/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Abdominal pain upper	2.5% 21/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.9% 16/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Infections and infestations Upper respiratory tract infection	2.2% 18/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.7% 15/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Gastrointestinal disorders Nausea	2.2% 18/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.1% 12/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Vaginal burning sensation	1.9% 16/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.3% 13/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Infections and infestations Sinusitis	1.7% 14/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.5% 14/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Vulvovaginal discomfort	1.4% 12/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.9% 16/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.
Reproductive system and breast disorders Vaginal odor	1.4% 12/836 The overall safety population includes only subjects that actually used the product at least once totalling 1396.	2.0% 11/560 The overall safety population includes only subjects that actually used the product at least once totalling 1396.