Contraception Clinical Trial
Official title:
Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users
NCT number | NCT03398811 |
Other study ID # | POCU |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | November 1, 2020 |
Verified date | December 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The use of progestin-only methods of contraception has been increased obviously and progressively over the world in the last few years. Progestin-only contraception is an option for women in whom an estrogen-containing contraceptive is either contraindicated or causes additional health concerns. Progestogen-only pills are contraceptive pills that contain only synthetic progestogens (progestins) and do not contain estrogen . The progestin-only pill is recommended over regular birth control pills for women who are breastfeeding because the mini-pill does not affect milk production. The most common progestin-only method used is the injectable depot medroxy-progesterone acetate which had been approved by Food and Drug Administration since 1992 . depot medroxy-progesterone acetate provides reliable, private, long-acting (three months) and reversible contraception. Users of depot medroxy-progesterone acetate don't need daily taking as well as it doesn't affect the intercourse by any mean. The etonogestrel implant (Implanon) is a single-rod progestin contraceptive method placed subdermally in the inner aspect of upper non dependant arm for three years. Much evidence supports the safety, efficacy, reversibility and acceptability of this contraceptive method. A common reason women choose to discontinue progestin-only contraception is dissatisfaction with its effects on uterine bleeding which occurs in a significant number of users. Information revealed from many clinical trials shows that abnormal uterine bleeding with progestin-only contraception ranging from 10 to 25 % at first year of use.
Status | Completed |
Enrollment | 390 |
Est. completion date | November 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Women aged between 18-40 years. 2. Women with more than 12 month postpartum. 3. Women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle length variation of no more than 5 days, bleeding days from 2-7 days and number of sanitary pads not more than 3 pads without blood clots or flooding of blood). 4. Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy prevention for at least 1 year. Exclusion Criteria: 1. Women on any anticoagulant therapy. 2. Women who had a history of uterine, cervical or ovarian pathology. 3. Women who had uterine bleeding disturbance (including amenorrhea) before recruitment. 4. Women received DMPA injection within the previous 9 months except they had three spontaneous regular menstrual cycles. 5. Severely anemic women (hemoglobin < 8gm/dl). 6. Women with any contraindications for POCs following the WHO eligibility (Altshuler AL et al., 2015). 7. Women refused to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Women Health Hospital - Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of women developed vaginal bleeding | 12 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02577601 -
Impact of Combined Hormonal Contraceptives on UPA
|
Phase 4 | |
Completed |
NCT03153644 -
Improving Contraceptive Care for Women With Medical Conditions
|
||
Completed |
NCT04112095 -
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
|
Phase 3 | |
Recruiting |
NCT05521646 -
Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative
|
N/A | |
Active, not recruiting |
NCT04291001 -
Ovarian Function With ENG Implant and UPA Use
|
Early Phase 1 | |
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Completed |
NCT03438682 -
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
|
||
Active, not recruiting |
NCT01948882 -
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
|
N/A | |
Enrolling by invitation |
NCT04997499 -
Adolescent Subcutaneous (SQ) Injection Video Validation
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03154125 -
Sayana® Press Extension Study
|
Phase 3 | |
Withdrawn |
NCT03725358 -
A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.
|
N/A | |
Completed |
NCT02957630 -
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
|
Phase 1/Phase 2 | |
Completed |
NCT02456584 -
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
|
Phase 1 | |
Completed |
NCT02718222 -
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
|
N/A | |
Recruiting |
NCT02121067 -
LNG-IUS at 2 Weeks Postpartum
|
Phase 4 | |
Terminated |
NCT02169869 -
Immediate Postplacental IUD Insertion
|
N/A | |
Recruiting |
NCT02292056 -
Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
|
N/A | |
Withdrawn |
NCT01930994 -
Kenya Sino-implant (II) PK Study
|
N/A |