Pericoital Oral Contraception With Levonorgestrel

• Sponsor: FHI 360 (Other)
• Overall Status: Completed
• CT.gov ID: NCT00922233
• Collaborator: (none)
• Enrollment: 72
• Locations: 4
• Arm: 1
• Duration (Months): 10
• Patients Per Site: 18
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: levonorgestrel	Phase 3

Detailed Description

This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study as stated in the study protocol are as follows:

• To evaluate the efficacy of the study regimen among women who have sex 1-4 days a month and who are relying on the study regimen as their primary method of contraception

• To evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia

• To evaluate the acceptability of the regimen The study will enroll fertile women of reproductive age who have sex up to 6 days a month, are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives,have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months (each tablet contains 0.75 mg LNG to be used after every sex act).

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Pericoital Oral Contraception With Levonorgestrel: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Acceptability
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levonorgestrel 0.75 mg of levonorgestrel within 24 hours of sex	Drug: levonorgestrel; oral contraceptive pills

Outcome Measures

Primary Outcome Measures

1. Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35) [6.5 months]

   Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived

2. Participant Report of Adverse Events. [6.5 months]

   Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken

Secondary Outcome Measures

1. Acceptability Based on Bleeding Patterns Reported [6.5 months]

   Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Each woman enrolled in the trial must meet the following inclusion criteria:

• Competent to provide informed consent to participate in the trial and has done so.

• At least the minimum age is 18 to 45 years old.

• Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months.

• At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following:

• More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months

• Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C

• Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma

• Sharing of illicit injection drug equipment ever in the past.

• Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs).

• Wants to avoid pregnancy for at least the next 6.5 months.

• Willing to accept an uncertain risk of pregnancy during the study.

• Gives correct answers to the informed consent quiz.

• Willing and able to follow all study requirements.

Exclusion Criteria:

To be eligible for enrollment, a woman must not meet any of the following exclusion criteria:

• Pregnant as verified by a pregnancy test at enrollment.

• Has an indication of current subfecundity, specifically:

• Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy

• She has not had normal monthly menses for the past 2 months

• She is currently breastfeeding

• She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period

• Has received an injection of a long term injectable contraceptive in the last 9 months

• Currently has an intrauterine device

• Has had a sterilization procedure or ectopic pregnancy

• Has been diagnosed by a clinician as having a fertility problem

• Her partner has had a sterilization procedure or infertility diagnosis, to her knowledge.

• She currently has known contraindications to progestin-only pills, specifically including the following conditions:

• Unexplained abnormal vaginal bleeding

• Deep venous thrombosis or pulmonary embolus

• Active viral hepatitis

• Decompensated cirrhosis

• Liver tumor

• History of breast cancer within the past 5 years.

• Has a breast mass on examination.

• Has a personal or family history suggestive of predisposition to thrombosis.

• Has a serious contraindication to pregnancy (medical condition or use of chronic medication such as isotretinoin or thalidomide).

• Taking drugs that are known to interact with progestins (such as rifampicin or anticonvulsant medications).

• Has previously participated in this study.

• Currently participating in another medical research study.

• The site investigator or designee perceives another reason to exclude her from the trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood of the Rocky Mountains	Denver	Colorado	United States	80232
2	Planned Parenthood Gulf Coast, Inc.	Houston	Texas	United States	77004
3	Planned Parenthood Association of Utah	Salt Lake City	Utah	United States	84102
4	CEMICAMP	Campinas		Brazil

Sponsors and Collaborators

• FHI 360

Investigators

• Principal Investigator: Vera Halpern, MD, FHI 360

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FHI 360
• ClinicalTrials.gov Identifier: NCT00922233
• Other Study ID Numbers: 10139
• First Posted: Jun 17, 2009
• Last Update Posted: Oct 29, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by FHI 360: Contraception
• Additional relevant MeSH terms: Levonorgestrel

Study Results

Participant Flow

Arm/Group Title	Levonorgestrel
Arm/Group Description	Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
Period Title: Overall Study
STARTED	72
COMPLETED	68
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Levonorgestrel
Arm/Group Description	0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
Overall Participants	72
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.4 (6.9)
Sex: Female, Male (Count of Participants)
Female	72 100%
Male	0 0%
Region of Enrollment (participants) [Number]
Africa	72 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)
Description	Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived
Time Frame	6.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levonorgestrel
Arm/Group Description	0.75 mg levonorgestrel oral contraceptive pills
Measure Participants	68
Number [pregnancies per 100 woman years]	22.4

2. Secondary Outcome

Title	Acceptability Based on Bleeding Patterns Reported
Description	Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel
Time Frame	6.5 months

Outcome Measure Data

Analysis Population Description

A total of 56 women reported on their bleeding patterns, of these, 43 found it acceptable. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.

Arm/Group Title	Levonorgestrel Arm
Arm/Group Description	Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
Measure Participants	56
Number [participants]	43 59.7%

3. Primary Outcome

Title	Participant Report of Adverse Events.
Description	Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken
Time Frame	6.5 months

Outcome Measure Data

Analysis Population Description

A total of 58 women documented use of product on coital diaries and are included in the User Population for primary safety analysis. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.

Arm/Group Title	Levonorgestrel Arm
Arm/Group Description	Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
Measure Participants	58
Number [adverse events]	45

Adverse Events

Arm/Group Title	Levonorgestrel Arm
Arm/Group Description	Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
All Cause Mortality
	Levonorgestrel Arm
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Levonorgestrel Arm
	Affected / at Risk (%)	# Events
Total	0/72 (0%)
Other (Not Including Serious) Adverse Events
	Levonorgestrel Arm
	Affected / at Risk (%)	# Events
Total	28/72 (38.9%)
Blood and lymphatic system disorders
anemia	10/72 (13.9%)	11
Gastrointestinal disorders
nausea	2/72 (2.8%)	2
vomiting	1/72 (1.4%)	1
General disorders
irritability	1/72 (1.4%)	1
Immune system disorders
hypersensitivity	1/72 (1.4%)	1
Infections and infestations
Cellulitis	1/72 (1.4%)	1
chlamydial infection	1/72 (1.4%)	1
ear infection	1/72 (1.4%)	1
influenza	1/72 (1.4%)	1
rhinitis	1/72 (1.4%)	1
sinusitis	1/72 (1.4%)	1
tonsilitis	1/72 (1.4%)	1
upper respiratory tract infection	2/72 (2.8%)	2
urinary tract infections	1/72 (1.4%)	1
vaginal candidiasis	5/72 (6.9%)	5
Musculoskeletal and connective tissue disorders
pain in extremity	1/72 (1.4%)	1
Nervous system disorders
headache	3/72 (4.2%)	4
Renal and urinary disorders
dysuria	1/72 (1.4%)	1
Reproductive system and breast disorders
cervical dysplasia	1/72 (1.4%)	1
decereased libido	1/72 (1.4%)	1
vaginal discharge	3/72 (4.2%)	3
Respiratory, thoracic and mediastinal disorders
cough	1/72 (1.4%)	1
Skin and subcutaneous tissue disorders
dermititis allergic	1/72 (1.4%)	1
seborrhea	1/72 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.