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Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel

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ClinicalTrials.gov Identifier: NCT01306331
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : July 30, 2020
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
Health Decisions
Information provided by (Responsible Party):
Evofem Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraception
Interventions Drug: Conceptrol
Drug: Amphora
Enrollment 3389
Recruitment Details Healthy, sexually active women at risk of pregnancy who desired contraception, aged 18 to 35 years, with a single male sex partner, of which both partners were at low risk for HIV and sexually transmitted disease (STD) infection. Subjects were required to have regular, normal, cyclic menses with a usual length of 21 to 40 days.
Pre-assignment Details The study had 65 randomized screen failures and were not included in the ITT population due to being accidentally randomized (30 randomized to Amphora™ Gel and 35 to Conceptrol®).
Arm/Group Title Conceptrol Amphora
Hide Arm/Group Description

100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel

Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

Citric acid USP, potassium bitartrate USP, and L-lactic acid USP

Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Period Title: Overall Study
Started 1659 1665
Completed 758 788
Not Completed 901 877
Reason Not Completed
Adverse Event             28             25
Lost to Follow-up             321             323
Physician Decision             26             22
Pregnancy             136             151
Protocol Violation             154             124
Withdrawal by Subject             163             152
Not sexually active             29             28
Meth. no longer prim. meth. birth cntrl             10             20
Other             34             32
Arm/Group Title Conceptrol Amphora Total
Hide Arm/Group Description

100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel

Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

Citric acid USP, potassium bitartrate USP, and L-lactic acid USP

Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Total of all reporting groups
Overall Number of Baseline Participants 1659 1665 3324
Hide Baseline Analysis Population Description
Intent-Treat-Population - subjects randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1659 participants 1665 participants 3324 participants
27.6  (5.7) 27.6  (5.6) 27.6  (5.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1659 participants 1665 participants 3324 participants
Female
1659
 100.0%
1665
 100.0%
3324
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1659 participants 1665 participants 3324 participants
Hispanic or Latino
385
  23.2%
392
  23.5%
777
  23.4%
Not Hispanic or Latino
1274
  76.8%
1272
  76.4%
2546
  76.6%
Unknown or Not Reported
0
   0.0%
1
   0.1%
1
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1659 participants 1665 participants 3324 participants
American Indian or Alaska Native
9
   0.5%
14
   0.8%
23
   0.7%
Asian
45
   2.7%
36
   2.2%
81
   2.4%
Native Hawaiian or Other Pacific Islander
13
   0.8%
9
   0.5%
22
   0.7%
Black or African American
464
  28.0%
471
  28.3%
935
  28.1%
White
1030
  62.1%
1031
  61.9%
2061
  62.0%
More than one race
98
   5.9%
102
   6.1%
200
   6.0%
Unknown or Not Reported
0
   0.0%
2
   0.1%
2
   0.1%
BMI Category at Enrollment (kg/m2)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1659 participants 1665 participants 3324 participants
Underweight (<18.5)
75
   4.5%
83
   5.0%
158
   4.8%
Normal (18.5 - 24.9)
672
  40.5%
640
  38.4%
1312
  39.5%
Overweight (25.0 - 29.9)
369
  22.2%
392
  23.5%
761
  22.9%
Obese (>30.0)
539
  32.5%
548
  32.9%
1087
  32.7%
BMI at Enrollment (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 1659 participants 1665 participants 3324 participants
27.76  (7.98) 27.91  (7.95) 27.83  (7.97)
1.Primary Outcome
Title 6-Month (183 Days) Cumulative Pregnancy Percentage
Hide Description The primary endpoint was the evaluation of contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the MITT population by treatment group
Time Frame 183 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population - ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as "Typical-Use"), between 18 to 35 years of age (inclusive) at enrollment, had at least 1 cycle without any backup contraception or EC, and for whom there was at least one report of pregnancy status.
Arm/Group Title Conceptrol Amphora
Hide Arm/Group Description:

100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel

Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

Citric acid USP, potassium bitartrate USP, and L-lactic acid USP

Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Overall Number of Participants Analyzed 1281 1259
Mean (95% Confidence Interval)
Unit of Measure: pregnancy percentage
10.0
(8.1 to 11.9)
10.5
(8.6 to 12.3)
2.Secondary Outcome
Title 6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use
Hide Description Perfect use contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the efficacy evaluable (EE) population by treatment group
Time Frame 183 days
Hide Outcome Measure Data
Hide Analysis Population Description
EE populations - a subset of the MITT population that includes only subjects with at least one EE cycle, where an EE cycle is a cycle where the diaries indicated they used the product correctly for every act of intercourse in the cycle.
Arm/Group Title Conceptrol Amphora
Hide Arm/Group Description:

100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel

Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

Citric acid USP, potassium bitartrate USP, and L-lactic acid USP

Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Overall Number of Participants Analyzed 1161 1161
Mean (95% Confidence Interval)
Unit of Measure: pregnancy percentage
4.2
(2.8 to 5.6)
4.1
(2.7 to 5.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conceptrol, Amphora
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments

Using Blackwelder's approach for non-inferiority testing, the null and alternative hypotheses are expressed as:

HO: πA > πC + 0.055 vs HA : πA < πC + 0.055

Statistical Test of Hypothesis P-Value 0.445
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 183 days
Adverse Event Reporting Description Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
 
Arm/Group Title Conceptrol Amphora
Hide Arm/Group Description

100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel

Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

Citric acid USP, potassium bitartrate USP, and L-lactic acid USP

Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

All-Cause Mortality
Conceptrol Amphora
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1477 (0.00%)   0/1458 (0.00%) 
Hide Serious Adverse Events
Conceptrol Amphora
Affected / at Risk (%) Affected / at Risk (%)
Total   19/1477 (1.29%)   11/1458 (0.75%) 
Cardiac disorders     
Wolff-Parkison-White syndrome  1  1/1477 (0.07%)  0/1458 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/1477 (0.07%)  0/1458 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/1477 (0.07%)  1/1458 (0.07%) 
Gastrointestinal hemorrhage  1  1/1477 (0.07%)  0/1458 (0.00%) 
Pancreatitis  1  1/1477 (0.07%)  0/1458 (0.00%) 
Pancreatitis acute  1  1/1477 (0.07%)  0/1458 (0.00%) 
Non-cardiac chest pain  1  1/1477 (0.07%)  0/1458 (0.00%) 
Infections and infestations     
Abdominal abscess  1  1/1477 (0.07%)  1/1458 (0.07%) 
Appendicitis  1  1/1477 (0.07%)  0/1458 (0.00%) 
Campylobacter gastroenteritis  1  1/1477 (0.07%)  0/1458 (0.00%) 
Gastroenteritis viral  1  0/1477 (0.00%)  1/1458 (0.07%) 
Kidney Infection  1  1/1477 (0.07%)  0/1458 (0.00%) 
Post procedural sepsis  1  1/1477 (0.07%)  0/1458 (0.00%) 
Pyelonephritis  1  2/1477 (0.14%)  1/1458 (0.07%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  0/1477 (0.00%)  2/1458 (0.14%) 
Investigations     
Investigation  1  1/1477 (0.07%)  0/1458 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  1/1477 (0.07%)  0/1458 (0.00%) 
Nervous system disorders     
Migraine  1  0/1477 (0.00%)  1/1458 (0.07%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy  1  3/1477 (0.20%)  1/1458 (0.07%) 
Reproductive system and breast disorders     
Ovarian rupture  1  0/1477 (0.00%)  1/1458 (0.07%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/1477 (0.00%)  2/1458 (0.14%) 
Pulmonary embolism  1  1/1477 (0.07%)  0/1458 (0.00%) 
Surgical and medical procedures     
Gastrectomy  1  1/1477 (0.07%)  0/1458 (0.00%) 
1
Term from vocabulary, MedDRA (14.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Conceptrol Amphora
Affected / at Risk (%) Affected / at Risk (%)
Total   857/1477 (58.02%)   793/1458 (54.39%) 
Infections and infestations     
Urinary Tract Infection  1  193/1477 (13.07%)  140/1458 (9.60%) 
Vaginitis Bacterial  1  170/1477 (11.51%)  160/1458 (10.97%) 
Vulvovaginal Mycotic  1  168/1477 (11.37%)  156/1458 (10.70%) 
Nasopharyngitis  1  48/1477 (3.25%)  76/1458 (5.21%) 
Vulvovaginal  1  46/1477 (3.11%)  45/1458 (3.09%) 
nfluenza  1  20/1477 (1.35%)  37/1458 (2.54%) 
Investigations     
Smear Cervix Abnormal  1  29/1477 (1.96%)  21/1458 (1.44%) 
Nervous system disorders     
Headache  1  80/1477 (5.42%)  96/1458 (6.58%) 
Renal and urinary disorders     
Dysuria  1  30/1477 (2.03%)  20/1458 (1.37%) 
Reproductive system and breast disorders     
Vulvovaginal Pruritus  1  76/1477 (5.15%)  55/1458 (3.77%) 
Vulvovaginal Discomfort  1  53/1477 (3.59%)  42/1458 (2.88%) 
Vulvovaginal Burning Sensation  1  41/1477 (2.78%)  49/1458 (3.36%) 
Vaginal Discharge  1  46/1477 (3.11%)  43/1458 (2.95%) 
Dysmenorrhoea  1  34/1477 (2.30%)  33/1458 (2.26%) 
1
Term from vocabulary, MedDRA (14.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Evofem
Phone: 858-550-1900
EMail: kculwell@evofem.com
Layout table for additonal information
Responsible Party: Evofem Inc.
ClinicalTrials.gov Identifier: NCT01306331    
Other Study ID Numbers: AMP001
First Submitted: February 28, 2011
First Posted: March 1, 2011
Results First Submitted: June 9, 2020
Results First Posted: July 30, 2020
Last Update Posted: August 14, 2020